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OBJECTIVE To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment. DESIGN Global phase 3, randomised, placebo-controlled superiority study. SETTING Study sites in the USA (n = 19) and Bulgaria (n = 18). POPULATION Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline. METHODS Patients were randomly assigned 2:1 to ibrexafungerp (300 mg twice for 1 day) or placebo. MAIN OUTCOME MEASURES The primary endpoint was the percentage of patients with a clinical cure (VSS = 0) at the test-of-cure visit (day 11 ± 3). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS ≤1) at test-of-cure visit, and complete resolution of symptoms at follow-up visit (day 25 ± 4). RESULTS At the test-of-cure visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure (63.3% [119/188] versus 44.0% [37/84]; P = 0.007), mycological eradication (58.5% [110/188] versus 29.8% [25/84]; P

Background Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC. Methods Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4). Results Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity. Conclusions Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.

Background Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis. Methods Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2 g or placebo. The primary endpoint was microbiological test of cure (TOC) by culture 6–12 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits, if needed. Fifty patients per group (N = 100) provided approximately 95% power to detect a statistically significant difference between treatment groups. Results Between April 2019 and March 2020, 147 women enrolled at 10 sites in the United States. The modified intention-to-treat (mITT) population included 131 randomized patients (secnidazole, n = 64; placebo, n = 67). Cure rates were significantly higher in the secnidazole vs placebo group for the mITT population (92.2% [95% confidence interval {CI}: 82.7%–97.4%] vs 1.5% [95% CI: .0%–8.0%]) and for the per-protocol population (94.9% [95% CI: 85.9%–98.9%] vs 1.7% [95% CI: .0%–8.9%]). Cure rates were 100% (4/4) in women with human immunodeficiency virus (HIV) and 95.2% (20/21) in women with bacterial vaginosis (BV). Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea (each 2.7%). No serious TEAEs were observed. Conclusions A single oral 2 g dose of secnidazole was associated with significantly higher microbiological cure rates vs placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and/or BV. Clinical Trials Registration NCT03935217., A single oral dose of secnidazole vs placebo significantly increased microbiological cure rates in women with trichomoniasis, including those with human immunodeficiency virus and/or bacterial vaginosis.

Background Vulvovaginal candidiasis (VVC) is a common cause of vulvovaginal itching and discharge. This article discusses the latest CDC STI Treatment Guidelines for VVC. Methods A literature search of relevant topics was performed, and a team of experts was convened to discuss (1) diagnosis/testing modalities; treatment of (2) uncomplicated VVC , (3) complicated VVC, and (4) VVC caused by non-albicans yeast; (5) alternative treatment regimens; (6) susceptibility testing of yeast; Special Populations: (7) pregnancy and (8) HIV and VVC. Results Yeast culture remains the gold standard for diagnoses. Newer molecular assays have been developed for the diagnosis of VVC and perform well. Azole antifungals remain the treatment of choice for uncomplicated VVC. Two new drugs, TOL-463 and recently FDA-approved ibrexafungerp, appeared promising in clinical trials. For recurrent VVC, oteseconazole, not yet commercially available, may represent a new option. For non-albicans yeast infections in symptomatic patients, boric acid appears useful. No evidence supports the use of alternative treatments, including probiotics. Fluconazole during pregnancy may be associated with spontaneous abortion and craniofacial and heart defects. In women with HIV infection, lower CD4+ T-cell counts are associated with increased rates of VVC, and VVC is associated with increased viral shedding. Treatment measures in women with HIV infection are identical to those women without HIV infection. Conclusions There has been significant new knowledge generated about VVC since the 2015 CDC Guidelines which have led to changing recommendations.

Background Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT-1161 vs fluconazole in participants with moderate to severe acute VVC. Methods Participants presenting with an acute episode of VVC (n = 55) were randomized to receive VT-1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days or to receive a single dose of fluconazole 150 mg (FDA-approved dose to treat acute VVC). Participants were followed for 6 months. The primary outcome was the proportion of participants with therapeutic (clinical and mycological) cure at day 28. Results A larger proportion of participants in the per-protocol population experienced therapeutic cure in the VT-1161 300 mg q.d. (75.0%), VT-1161 600 mg q.d. (85.7%), and VT-1161 600 mg b.i.d. (78.6%) groups vs the fluconazole group (62.5%); differences were not statistically significant. At 3 and 6 months, no participants in the VT-1161 groups vs 28.5% and 46.1% in the fluconazole group, respectively, had evidence of mycological recurrence. No serious adverse events or treatment-emergent adverse events leading to discontinuation were reported. Conclusions The majority of participants across all treatment groups achieved therapeutic cure at day 28. VT-1161 was well tolerated at all dose levels through 6 months of follow-up. Clinical Trials Registration NCT01891331., In a phase 2 randomized clinical study, VT-1161, a novel antifungal agent, was shown to be safe and efficacious in women with acute vaginal candidiasis.

Recurrent vulvovaginal candidiasis (RVVC) has significant disease, financial and quality-of-life burdens, affects women from all strata of society worldwide, and lacks an approved therapeutic solution. Fluconazole emerged in 2004 as an antifungal for RVVC; it provides symptom control and has been accepted worldwide as a first-line treatment. Its limitations include the development of resistance and a high rate of vulvovaginal candidiasis recurrence after therapy cessation. There is now an improved treatment option on the horizon: oteseconazole - a novel, oral, selective fungal cytochrome P450 enzyme 51 inhibitor, designed to avoid off-target toxicities. In clinical studies to date, oteseconazole has demonstrated impressive efficacy, a positive tolerability profile and hope for a superior RVVC treatment option.Lay abstract Many women are affected by vaginal fungal infections, also called yeast infections. These infections can affect normal daily activities and have negative emotional and financial effects as well, especially for women who have yeast infections repeatedly. There is no US FDA-approved treatment for repeated yeast infections although the symptoms are often managed with a prescription antifungal medication, fluconazole. However, using fluconazole can have health risks, especially when it is used repeatedly over months or years. Another problem is that the yeasts that cause the infection can become resistant to the treatment. A new medication has been developed and tested in clinical studies and may soon provide women with an effective treatment option for repeated yeast infections that is also safer.

Background Vulvovaginal candidiasis (VVC) is a common infection affecting women worldwide. Reports of patterns/risk factors/trends for episodic/recurrent VVC (RVVC) are largely outdated. The purpose of this study was to obtain current patient perspectives of several aspects of VVC/RVVC. Methods Business cards containing on-line survey information were distributed to healthy volunteers and patients seeking standard, elective, or referral gynecologic care in university-affiliated Obstetrics/Gynecology clinics. The internet-based questionnaire was completed by 284 non-pregnant women (78% Caucasian, 14% African American, 8% Asian). Results The majority of the participants (78%) indicated a history of VVC with 34% defined as having RVVC. The most common signs/symptoms experienced were itching, burning and redness with similar ranking of symptoms among VVC and RVVC patients. Among risk factors, antibiotic use ranked highest followed by intercourse, humid weather and use of feminine hygiene products. A high number of respondents noted ‘no known cause’ (idiopathic episodes) that was surprisingly similar among women with a history of either VVC or RVVC. VVC/RVVC episodes reported were primarily physician-diagnosed (73%) with the remainder mostly reporting self-diagnosis and treating with over-the-counter (OTC) medications. Most physician-diagnosed attacks utilized a combination of pelvic examination and laboratory tests followed by prescribed antifungals. Physician-treated cases achieved a higher level of symptom relief (84%) compared to those who self-medicated (57%). The majority of women with RVVC (71%) required continual or long-term antifungal medication as maintenance therapy to control symptoms. Conclusions Current patient perspectives closely reflect historically documented estimates of VVC/RVVC prevalence and trends regarding symptomatology, disease management and post-treatment outcomes. Electronic supplementary material The online version of this article (10.1186/s12905-019-0748-8) contains supplementary material, which is available to authorized users.

Background Vulvovaginal candidiasis affects approximately 75% of women in their lifetime. Approved treatment options are limited to oral or topical azoles. Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile. The primary objective of this dose-finding study was to identify the optimal dose of oral ibrexafungerp in patients with acute vulvovaginal candidiasis. Methods Patients with vulvovaginal signs and symptoms score ≥7 were randomized equally to 6 treatments groups: 5 treatment doses of oral ibrexafungerp or oral fluconazole 150 mg. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms) at the test-of-cure visit (day 10). Results Overall, 186 patients were randomized into the 6 treatment groups. Results, using the modified intent-to-treat population (baseline positive culture), are reported for ibrexafungerp 300 mg twice daily (BID) for 1 day (n = 27), which was the dose selected for phase 3 studies, and fluconazole 150 mg for 1 day (n = 24). At day 10, the clinical cure rates for ibrexafungerp and fluconazole were 51.9% and 58.3%, respectively; at day 25, patients with no signs or symptoms were 70.4% and 50.0%, respectively. During the study ibrexafungerp patients required less antifungal rescue medications compared with fluconazole (3.7% vs 29.2%, respectively). Ibrexafungerp was well tolerated, with the most common treatment-related adverse events being mild gastrointestinal events. Conclusions Ibrexafungerp is a well-tolerated novel antifungal with comparable efficacy to fluconazole in the treatment of acute vulvovaginal candidiasis. Clinical Trials Registration NCT03253094

Vaginitis is one of the main causes of primary care and gynecological visits in the United States. The most common infectious causes are bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis. A physician survey was conducted to measure awareness of vaginitis clinical guidelines and availability of in-office point-of-care (POC) diagnostic tools. Participants were asked to perform a chart review to evaluate diagnostic practices for their symptomatic vaginitis patients. A total of 333 physicians and 984 patient charts were included. Physicians were most familiar with VVC and BV diagnostic guidelines; fewer than half were aware of current trichomoniasis guidelines. Although access to POC tools used to evaluate and diagnose vaginitis varied by practice, there was limited access to all 3 tools (microscope, pH test strips, potassium hydroxide solution) required to perform a full Amsel workup for BV (47% obstetricians/gynecologists vs. 32% primary care physicians, P

Cytolytic vaginosis is a controversial condition that some clinicians have traditionally included as a potential cause of vulvovaginal symptoms despite the lack of scientific evidence. Recent articles have focused on the evaluation of patients once they carry the diagnosis of cytolytic vaginosis, rather than on diagnostic criteria. Our review revealed inadequate criteria for excluding other causes of vulvovaginal symptoms, especially VVC, when diagnosing women with cytolytic vaginosis. Treatment recommendations have remained stagnant with no single case report or case series with detailed information about affected patients. Finally, with the inconsistencies in sampling sites and inadequacies in sampling techniques across studies, the reported evidence of lactobacilli overgrowth is unreliable and cannot be used to support the diagnosis of cytolytic vaginosis. Any future investigations of the condition would need to have strict criteria for diagnosis which can be reproduced by other investigators, so that common ground for diagnosis can begin as a basis for studies. We further recommend that any study evaluating patient treatments include information about patient demographics, details about their treatment, and the results in terms of changes in symptoms and findings.

Objective The purpose of this study is to determine the optimal sequence in performing a pelvic examination to reduce discomfort in patients with baseline vaginal pain. Methods A randomized controlled trial of women presenting for a new appointment at the Drexel Vaginitis Center was conducted. Women were assigned to either group A, a Q-tip touch test, speculum examination, then bimanual examination, or group B, a Q-tip touch test, bimanual examination, then speculum examination. The primary outcome was visual analog scales to assess pain at baseline and after each portion of the examination. Secondary outcomes were responses to questionnaires for self-esteem, quality of life, and sexual function. Results Two hundred women were enrolled in the trial. For both group A and group B, each portion of the examination was similarly scored regardless of whether the speculum examination was performed before or after bimanual examination. Pain during the speculum examination was higher than pain during the other components of the examination, although not significant (P = 0.65).When looking at reported pain outcomes, outcomes did not differ as a whole or between groups in relation to sexual activity, sexual orientation, and previous hysterectomy. The data were not significantly different between groups for self-esteem scores, sexual dysfunction, or quality of life scores. Conclusion In women with baseline vaginal pain, there was no difference in pain scores between the different components of the pelvic examination, nor is there a significant difference in pain during the examination compared with their baseline pain. Most patients reported minimal pain during each component.

Objectives The aim of this study was to evaluate the efficacy of the fractionated CO2 laser in treating recalcitrant lichen sclerosus (LS). Materials and methods The study population was 40 women diagnosed with LS who were symptomatic despite medical treatment. Patients had at least 2 or more laser sessions with a 2-month follow-up visit at the Drexel Vaginitis Center. A fractionated CO2 laser was used on affected areas at mild or standard power settings. Analyses were performed of changes in symptom rating scales, verbal reports, and physical examination findings. Results In the LS cohort of 40 patients, 22 women (55%) experienced symptoms that had persisted longer than 5 years before treatment. After the appropriate laser sessions, 72.5% of women described their improvement as significant or more than 66% improvement. In addition, there was a statistically significant reduction in vaginal pain, itching, dyspareunia, and dysuria. The presence of white epithelium decreased 20% after treatment. Furthermore, the mean corticosteroid use declined from 4.28 times per week to 2.04 times per week, indicating a resolution of many symptoms. Conclusions The fractionated CO2 laser may be a helpful approach for managing LS that is unresponsive to traditional treatment options.

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis., Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis. The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis. Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis. Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians’ diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians’ diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

Background Recurrent vulvovaginal candidiasis (RVVC) is a problematic form of mucosal Candida infection, characterized by repeated episodes per year. Candida albicans is the most common cause of RVVC. Currently, there are no immunotherapeutic treatments for RVVC. Methods This exploratory randomized, double-blind, placebo-controlled trial evaluated an immunotherapeutic vaccine (NDV-3A) containing a recombinant C. albicans adhesin/invasin protein for prevention of RVVC. Results The study in 188 women with RVVC (n = 178 evaluable) showed that 1 intramuscular dose of NDV-3A was safe and generated rapid and robust B- and T-cell immune responses. Post hoc exploratory analyses revealed a statistically significant increase in the percentage of symptom-free patients at 12 months after vaccination (42% vaccinated vs 22% placebo; P = .03) and a doubling in median time to first symptomatic episode (210 days vaccinated vs 105 days placebo) for the subset of patients aged

Trichomonas vaginalis is the most prevalent sexually transmitted parasite in the USA; resistant infection is emerging. New drug therapies and dosing regimens of standard therapies are being studied to treat resistant infection. Diagnosis of trichomoniasis has become more sensitive, specific, and widely available with the advent of nucleic acid amplification tests (NAATs). Women with resistant trichomoniasis should be treated with high-dose regimens of metronidazole or tinidazole. Alternative treatment options have been described, and there has been some success particularly with high-dose tinidazole/intravaginal paromomycin cream combination, intravaginal boric acid, and intravaginal metronidazole/miconazole. Resistant trichomoniasis is a growing public health concern with implications for long-term health consequences. More data are needed to further evaluate mechanisms by which resistance occurs as well as promising therapies for those affected.

Objectives Vulvovaginal candidiasis (VVC) is an infection of the vagina's mucous membranes, caused by Candida albicans in more than 90% of acute VVC. Several topical and oral azole agents are available in a variety of formulations, and all seem to have similar effectiveness. Azoles are fungistatic, meaning that the fungi are inhibited from growth or replication but are not eradicated. Recurrent infection and developing azole resistance demonstrate a significant need for alternative treatments. Materials and methods One hundred twenty-six women were randomized to 1 of the following 3 treatment cohorts: CD101 3% gel (n = 50) applied intravaginally on days 1 and 2, CD101 6% ointment (n = 50) applied intravaginally on day 1, or oral fluconazole 150 mg (n = 26) on day 1. Primary outcomes of clinical and mycological cure, as demonstrated by changes in the vaginal scores and mycological culture, were assessed on day 7 (±2 days), day 14 (±2 days), and day 28 (±7 days). Safety assessments included treatment-emergent adverse events. Results Ninety-nine women with positive Candida culture remained in the modified intent-to-treat population with 40 in each CD101 arm and 19 in the fluconazole arm. In the CD101 gel, CD101 ointment, and oral fluconazole groups, 35%, 30%, and 52.6% demonstrated clinical cure and 45%, 40%, and 57.9% had mycological cure at day 28, respectively. Conclusions CD101 3% gel and CD101 6% ointment were well tolerated and produced similar rates of clinical and mycological cure in patients with an acute, moderate-to-severe episode of VVC. However, cure rates for these 2 formulations and regimens of CD101 were lower than those in patients treated with fluconazole.

Data about long-term clinical outcome after a course of maintenance fluconazole in those with recurrent vulvovaginal candidiasis (RVVC) is lacking. We aimed to determine the rate of recurrence at a minimum of 6 months after completion of maintenance therapy.A retrospective analysis of women with Candida albicans RVVC from January 2008 to January 2017 was performed using chart review to obtain information about recurrence after maintenance therapy. Patients were considered resolved if they had no further episodes of candidiasis, sporadic with less than 3 episodes yearly and ongoing with greater than 3 episodes yearly.Approximately 1,672 patients with C. albicans vaginal isolates were identified. Of these, 201 met the criteria for RVVC. The mean age was 40.4 years; 151 (77.4%) were white, 133 (66.2%) had comorbid vulvar conditions, and 76 (37.8%) had a risk factor for vulvovaginal candidiasis. One hundred twenty complete charts were further analyzed. The mean length of follow-up after discontinuing maintenance therapy was 39.9 months. After the initial course, 23 (19.2%), 21 (17.5%), and 76 (63.3%) were resolved, sporadic and ongoing, respectively. Risk factors, comorbid vulvar conditions, obesity, menopause status, and length of therapy were not associated with relapse. Age 40 or older was associated with relapse (p = .018). Of the 201 total patients with RVVC, 22 (10.9%) of patients self-reported at least 1 adverse event. The most common was gastrointestinal symptoms (8 [4%]).Although RVVC can be controlled, relapse is common after an initial course of maintenance fluconazole. Ongoing maintenance remains the most effective treatment option.

Secnidazole is a next-generation 5-nitroimidazole approved for more than three decades in Europe, Asia, South America and Africa and recently in the USA as a single-dose (2 g) treatment of bacterial vaginosis (BV). Secnidazole is characterized by potent in vitro antimicrobial activity against BV-associated pathogens, as well as prolonged terminal elimination half-life and systemic exposure. These characteristics form the basis of effective and safe treatment of BV with a 2-g single-dose secnidazole regimen, which was recently confirmed in double-blind, placebo-controlled clinical trials conducted in the USA. The option to treat BV with single-dose secnidazole not only cures the primary infection but also may diminish risks of serious sequelae of untreated or undertreated infection.

Metronidazole-resistant trichomoniasis is an uncommon condition that presents significant therapeutic challenges. Combination therapy with high-dose oral tinidazole and vaginal paromomycin cream has been uniformly successful. We present a case report of a patient who responded to combination therapy with high-dose oral tinidazole and intravaginal paromomycin.

Background Trichomonas vaginalis infection (TVI) is one of the most common sexually transmitted diseases in the United States. We sought to determine the features of TVI in a referral-based vaginitis center, focusing on diagnosis and treatment of difficult cases. Methods We conducted a retrospective review of all patients with TVI, based on International Classification of Diseases, Ninth Revision codes, seen at the Drexel Vaginitis Center between January 2008 and November 2013. Information collected on each subject included demographics, symptoms, examination findings, diagnostic tests, and treatment regimens. Results Of approximately 4000 new patient visits during our study period, 80 subjects were identified with TVI. Twenty subjects presented with known TVI, with most having clinically resistant infections. Diagnosis was confirmed by saline microscopy in 45%, OSOM rapid test in 40%, and clinical history in the remaining 15%. Treatment regimens varied: 20% received single 2-g dosing of either metronidazole or tinidazole, 50% received high-dose regimens, 20% received therapy with vaginal paromomycin, and 10% underwent desensitization for nitroimidazole allergy. Sixty subjects had newly diagnosed TVI, with 35% diagnosed by saline microscopy, 41.7% by OSOM rapid test, and 23.3% by APTIMA. Treatment regimens for these subjects included single 2-g dosing in 88.3%, high-dose regimen in 8.3%, and other formulations in the remaining 3.4%. In total, 80% of our subjects returned for follow-up; all of whom were cured. Conclusions T. vaginalis infection is a rare condition in a tertiary care vaginitis center and often requires nonstandard treatments. Among those who returned for follow-up, the cure rate was 100%.

An understanding of how the vaginal flora is influenced by hormonal status is crucial in distinguishing normal from abnormal secretions. New studies exploring the vaginal microbiome with culture-independent techniques have led to the discovery of previously uncultivable bacteria on a species level, and have contributed to a better understanding of disease processes including bacterial vaginosis. It is important to note that not all vaginal discharge is abnormal or infectious in etiology, but a thorough evaluation will help reassure both the patient and the provider.

Metronidazole vaginal gel 1.3% once daily for 1, 3, or 5 days provides similar efficacy, safety, and tolerability as metronidazole vaginal gel 0.75% once daily for 5 days., Objective Metronidazole vaginal gel (MVG) 0.75% is a US Food and Drug Administration–approved, 5-day treatment for bacterial vaginosis (BV). This study tested the hypothesis that a shorter treatment course at a higher dose (MVG 1.3%) would yield similar efficacy to 5 days of MVG 0.75%. Materials and Methods This phase 2, multicenter, randomized, controlled, investigator-blinded, dose-ranging study enrolled women with a clinical diagnosis of BV. Patients were assigned to MVG 1.3% once daily for 1, 3, or 5 days or MVG 0.75% once daily for 5 days. The therapeutic cure rate, requiring clinical and bacteriological cure, at the end-of-study visit was determined for the per-protocol population. A Kaplan-Meier analysis was used to estimate median time-to-symptom resolution. Results In total, 255 women (mean age = 35 y) were enrolled. The per-protocol population included 189 patients. The therapeutic cure rate was higher in the 1-day (13/43, 30.2%), 3-day (12/48, 25.0%), and 5-day (16/49, 32.7%) MVG 1.3% groups versus the MVG 0.75% group (10/49, 20.4%). Median time-to-resolution of fishy odor was shorter in the 3 MVG 1.3% groups versus the MVG 0.75% group. The 5-day MVG 1.3% group had the lowest rate of symptom return. No clinically important differences were observed in adverse events across treatment groups; most events were mild or moderate in intensity and considered unrelated to treatment. Similar results were found in the modified intent-to-treat population. Conclusions Metronidazole vaginal gel 1.3% applied once daily for 1, 3, or 5 days showed similar efficacy, safety, and tolerability as MVG 0.75% once daily for 5 days.

To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study.In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21-30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0-3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent to treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. Assuming a clinical cure rate of 40% in the active groups and 15% in the placebo group, a sample size of 52 patients per group provided approximately 80% power to detect a significant difference between groups (.05 level [two-sided]) using a Cochran-Mantel-Haenszel test.Between May and September 2014, 215 patients were enrolled. In the intent-to-treat population, the clinical cure rate was 65.3% for the 2-g group, 49.3% for the 1-g group, and 19.4% for the placebo group. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year; 54% black) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (P.05 for secnidazole compared with placebo; all endpoints). Both doses were well-tolerated.Oral granules containing 1 and 2 g secnidazole were superior to placebo in bacterial vaginosis treatment (P.001 for both groups). These data support the development of secnidazole for bacterial vaginosis treatment.ClinicalTrials.gov, NCT02147899.

Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs. We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with clinician-collected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were evaluated by the molecular test and six tests. The reference methods for bacterial vaginosis were Nugent's score and Amsel's criteria for intermediate Nugent results. The reference methods for Candida infection were isolation of any potential Candida microorganisms from inoculation of two culture media: chromogenic and Sabouraud agar and sequencing. The reference methods for trichomoniasis were wet mount and culture. For clinician-collected swabs, by reference methods, bacterial vaginosis was diagnosed in 56.5%, vaginal candidiasis in 32.8%, trichomoniasis in 8%, and none of the three infections in 24% with a coinfection rate of 20%. The investigational test sensitivity was 90.5% (95% confidence interval [CI] 88.3–92.2%) and specificity was 85.8% (95% CI 83.0–88.3%) for bacterial vaginosis. The investigational test sensitivity was 90.9% (95% CI 88.1–93.1%) and specificity was 94.1% (95% CI 92.6–95.4%) for the Candida group. Sensitivity for Candida glabrata was 75.9% (95% CI 57.9–87.8%) and specificity was 99.7% (95% CI 99.3–99.9%). Investigational test sensitivity was 93.1% (95% CI 87.4–96.3%) and specificity was 99.3% (95% CI 98.7–99.6%) for trichomoniasis. Results from self-collected swabs were similar to clinician-collected swabs. A molecular-based test using vaginal swabs collected by clinicians or patients can accurately diagnose most common bacterial, fungal, and protozoan causes of vaginitis. Women and their clinicians seeking accurate diagnosis and appropriate selection of efficacious treatment for symptoms of vaginitis might benefit from this molecular test.

Objective This study aimed to report the case of a patient who developed an iliopsoas abscess after a dilation and evacuation for a midtrimester fetal demise. Materials and methods This is a case report of a 35-year-old woman who underwent a dilation and evacuation at 17 weeks' gestation because of a preterm premature rupture of membranes and fetal demise. Four days later, she presented with fevers, chills, malaise, and right lower back, hip, and thigh pain. Magnetic resonance imaging of the abdomen and pelvis revealed a 2.3 × 1.6-cm right iliopsoas abscess. Results The patient underwent computed tomography-guided drainage of the abscess and made an uneventful recovery after completion of an antibiotic course and physical therapy. Conclusions An iliopsoas abscess should be considered in the differential diagnosis of any woman presenting with fevers, chills, and unilateral lower back, hip, and thigh pain in a radicular pattern after a recent dilation and evacuation.

Background Sexual dysfunction is common in women with vulvodynia. Objective The purpose of this study was (1) to evaluate whether extended-release gabapentin is more effective than placebo in improving sexual function in women with provoked vulvodynia and whether there is a relationship between treatment outcome and pelvic pain muscle severity that is evaluated by palpation with standardized applied pressure and (2) to evaluate whether sexual function in women with provoked vulvodynia would approach that of control subjects who report no vulvar pain either before or after treatment. Study Design As a secondary outcome in a multicenter double-blind, randomized crossover trial, sexual function that was measured by the Female Sexual Function Index was evaluated with gabapentin (1200–3000 mg/d) compared with placebo. Pain-free control subjects, matched by age and race, also completed Female Sexual Function Index for comparison. Results From August 2012 to January 2016, 230 women were screened at 3 academic institutions, and 89 women were assigned randomly to treatment. Gabapentin was more effective than placebo in improving overall sexual function (adjusted mean difference, 1.3; 95% confidence interval, 0.4–2.2; P=.008), which included desire (mean difference, 0.2; 95% confidence interval, 0.0–3.3; P=.04), arousal (mean difference, 0.3; 95% confidence interval, 0.1–0.5; P=.004), and satisfaction (mean difference, 0.3; 95% confidence interval, 0.04–0.5; P=.02); however, sexual function remained significantly lower than in 56 matched vulvodynia pain-free control subjects. There was a moderate treatment effect among participants with baseline pelvic muscle pain severity scores above the median on the full Female Sexual Function Index scale (mean difference, 1.6; 95% confidence interval, 0.3–2.8; P=.02) and arousal (mean difference, 0.3; 95% confidence interval, 0.1–0.6; P=.01) and pain domains (mean difference, 0.4; 95% confidence interval, 0.02–0.9; P=.04). Conclusion Gabapentin improved sexual function in this group of women with provoked vulvodynia, although overall sexual function remained lower than women without the disorder. The most statistically significant increase was in the arousal domain of the Female Sexual Function Index that suggested a central mechanism of response. Women with median algometer pain scores >5 improved sexual function overall, but the improvement was more frequent than the pain domain. We hypothesize that gabapentin may be effective as a pharmacologic treatment for those women with provoked vulvodynia and increased pelvic muscle pain on examination.

Chronic nongonococcal nonchlamydial cervicitis is a condition of unknown etiology. Data about treatment options are limited. Our goal was to review a single center's experience in managing women with chronic NGNCC.We evaluated all encounters at a tertiary care center with ICD-9 code for cervicitis between April 2008 and March 2014. Cases were defined by having two of the following 3 diagnostic criteria: mucopurulent discharge noted by (1) patient or (2) practitioner, and (3) cervical bleeding upon gentle probing. All women had negative nucleic acid amplification testing for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis. Information regarding patient demographics, symptoms, findings, treatment, and outcomes were analyzed. Cure was defined as resolution of patient-specific diagnostic criteria.Sixty-one women were identified. The mean age was 31 years; 73.7% were white, and 59% were nulliparous. The mean duration of symptoms was 25.2 months. Initially, all 61 patients received one of 3 antibiotic treatments. The cure rate after initial antibiotic treatment was 65.6%. Nineteen patients required at least one further treatment. Additional treatments included secondary antibiotics, hormonal treatments, vaginal hydrocortisone, silver nitrate, cryotherapy, and loop excision electrosurgical procedure. Cure rates were as follows: 57.9% with antibiotics, 50% with hormone treatment, 0% with hydrocortisone, 100% with silver nitrate, 0% with cryotherapy, and 100% with loop electrosurgical excisional procedure. Of the initial 61 women, 93.4% were eventually cured.Nongonococcal nonchlamydial cervicitis is a condition that can cause unremitting symptoms. Most patients will respond to antibiotics, although other treatments including surgery may be necessary.

Genital malodor is a common distressing complaint that brings a woman to her physician's office. Vaginal infections, primarily bacterial vaginosis and trichomoniasis, still remain the commonest causes and are relatively easy to diagnose and treat. However, in approximately one third of women who present with malodor, no cause is identified. Although data on the management of vaginal discharge are extensive, the management of genital odor beyond common vaginal infections remains poorly studied. This presents a frustrating situation for both the patient and her physician. Often, patients resort to home remedies and over-the-counter preparations, which, while providing short-term relief for some women, almost never address the cause and, in some cases, can exacerbate symptoms. In this review, we have attempted to consolidate the known and documented causes of genital malodor including the nonvaginal causes and provide case studies that will help clinicians understand the possible settings for the various causes. We also provide an algorithm for the management of this symptom beyond vaginal infections.

To describe the use of complementary alternative medicines in women with chronic vaginitis and to evaluate epidemiologic factors associated with these treatments.In this prospective cohort study, patients with chronic vaginitis completed a questionnaire about past diagnoses and treatments. Information regarding demographics, medical and social history, perceived mental and emotional stress, and current symptoms was collected. All patients underwent a standard physical examination and laboratory testing and were assigned a specific diagnosis.A total of 481 women were enrolled; 64.9% used complementary alternative medicines. The most common treatments were yogurt and acidophilus pills. In univariate analysis, compared with nonusers, users of complementary alternative medicines were younger (83.4% younger than 50 compared with 73.1%; P=.032), not African American (11.9% compared with 21.3%; P=.018), had increased measures of perceived stress (P=.008), and reported that their symptoms interfered with both work (59.1% compared with 40.6%; P=.001) and social lives (57.9% compared with 40.2%; P=.001). Patients using complementary alternative medicines had seen more doctors (median 2 compared with 1; P.001) and were more likely to report a history of vulvovaginal candidiasis (98.4% compared with 90.5%; P.001) or bacterial vaginosis (34.3% compared with 22.8%; P=.007). In the multivariable analysis, interference with social life, higher number of doctors seen, symptoms of itching or burning, and previous diagnoses of yeast infection remained associated with alternative medicine use. A current diagnosis of vulvovaginal candidiasis was not associated with alternative medicine use.Complementary alternative medicine use is common in women with chronic vaginitis, particularly in those who are young, have more disruptive symptoms, and report greater stress.II.

Genital mycoplasmas are commonly found in the female genital tract. Despite ongoing debate, the evidence that they cause lower genital tract disease in women remains sparse. The data that Mycoplasma genitalium is primarily transmitted sexually are accumulating, but its role as a cause of symptomatic urethritis or cervicitis is open to debate. Although Mycoplasma hominis may be a co-factor in bacterial vaginosis, it has otherwise not been implicated as a cause of lower tract disease. Now that Ureaplasma urealyticum has been divided into U. urealyticum and Ureaplasma parvum, their role in causing urethritis and cervicitis remains even more unclear. To date, no convincing evidence exists that antimicrobial therapy should be directed solely at these organisms when treating women with urethritis, bacterial vaginosis, trichomoniasis, or cervicitis.

Background Lanosterol demethylase is an enzyme that is essential for fungal growth and catalyzes an early step in the biosynthetic pathway of ergosterol, which is a sterol that is required for fungal cell membrane formation and integrity. Lanosterol demethylase is the molecular target of the class of drugs referred to as “azole antifungals.” VT-1161 is a novel, oral, selective inhibitor of fungal lanosterol demethylase and is being developed for the treatment of recurrent vulvovaginal candidiasis. Objective We evaluated the efficacy and safety of 4 dosing regimens of oral VT-1161 compared with placebo in women with recurrent vulvovaginal candidiasis, which was defined as at least 3 symptomatic episodes of acute vulvovaginal candidiasis within a 12-month period. Study Design Two hundred fifteen women with a documented history of recurrent vulvovaginal candidiasis and who, at screening, were experiencing an episode of acute vulvovaginal candidiasis (acute vulvovaginal candidiasis; composite vulvovaginal signs and symptoms score of ≥3 and a positive potassium hydroxide test for yeast) were enrolled. After treatment of the acute infection with fluconazole, subjects were assigned randomly to 1 of 5 treatment regimens: (1) VT-1161 150 mg once daily for 7 days, then 150 mg once weekly for 11 weeks, followed by a once-weekly dose of placebo for 12 weeks; (2) VT-1161 300 mg once daily for 7 days, then 300 mg once weekly for 11 weeks, followed by a once-weekly dose of placebo for 12 weeks; (3) VT-1161 150 mg once daily for 7 days, then 150 mg once weekly for 23 weeks; (4) VT-1161 300 mg once daily for 7 days, then 300 mg once weekly for 23 weeks; or (5) a matching placebo regimen for 24 weeks. The primary efficacy outcome was the proportion of subjects with ≥1 culture-verified acute vulvovaginal candidiasis episodes through week 48. Results In the intent-to-treat population, the proportion of subjects with ≥1 acute vulvovaginal candidiasis episodes ranged from 0–7% across the 4 VT-1161 arms vs 52% in the placebo arm, with all arms achieving statistical significance vs placebo. VT-1161 was well-tolerated with a favorable safety profile, and the incidence of adverse events was lower in all VT-1161 arms compared with placebo. In addition, no patient in any VT-1161 arm discontinued the study early because of an adverse event or laboratory abnormality. There was also no evidence of an adverse effect of VT-1161 on liver function or electrocardiogram recordings. Conclusion In this study, VT-1161 was shown to be efficacious and safe in the treatment of patients with recurrent vulvovaginal candidiasis. These data strongly support further clinical investigation of VT-1161 for the treatment of recurrent vulvovaginal candidiasis.

Epstein-Barr virus (EBV) is best known as the organism responsible for the syndrome of acute infectious mononucleosis. Transmission of EBV most commonly occurs through oral secretions. EBV has also been isolated from the female genital tract, where its role is poorly understood. This article reviews the available literature and data regarding EBV in the female genital tract and discusses areas of consensus and controversy. The primary manifestation of EBV seems to be vulvar ulcers, which are underrecognized. Diagnosis relies on appropriate serologic testing. Management includes local care and may require pain and corticosteroid medications. Although EBV is present elsewhere in the female genital tract, its pathogenic role in the cervix, uterus, fallopian tubes, and ovaries is poorly understood.

To evaluate the effectiveness of amitriptyline 2%/baclofen 2% cream (ABC) in treating provoked vestibulodynia (PV). In this retrospective evaluation of patients with PV who received ABC, women who had PV and met entry criteria were identified from a database of women with chronic vulvovaginal disorders. Treatment consisted of a cream containing 2% amitriptyline and 2% baclofen. Response was assessed using verbal report, visual analog scales of discomfort with daily and sexual activities, and 5-point numerical scales rating extent of interference with social activities, intercourse frequency, sexual desire, difficulty in lubrication, frequency and overall level of discomfort during sex, and satisfaction with overall sexual life. Data were available for 38 patients, with a median follow-up of 33 weeks. Overall, 29% patients reported no or little ( 60%) improvement. On self-administered questionnaires, patients reported a decrease in the extent to which the condition interfered with social activities (p =.017), easier lubrication (p =.022), and lower level of pain with intercourse (p =.05). No change was noted in the reported frequency of sexual intercourse, sexual desire, or satisfaction with sexual life. No patients had systemic side effects. Our data are limited by the retrospective study design and the lack of a control group. Nevertheless, given a response rate of 71% in women with refractory symptoms and the overall tolerability of this treatment, we suggest that ABC therapy warrants further investigation as a therapy for PV.

Vulvovaginal candidiasis (VVC) and bacterial vaginosis (BV) are frequently encountered in clinical practice. Recent advances have furthered understanding of pathophysiology. Proper diagnosis, based on appropriate office and, in complicated cases, laboratory tests is the key to rational selection of therapy. For women who have routine uncomplicated episodes of VVC or BV, a variety of effective treatment options exists. Recurrent disease remains a challenge for these conditions but can often be managed successfully.

Problem To determine the best method to detect semen in human vaginal secretions. Method of study Vaginal secretions from 302 pregnant women at mean 11.8 weeks’ gestation were analyzed. Semen detection was assessed with: (i) measurement of total prostate-specific antigen (PSA), (ii) acid phosphatase activity, (iii) microscopic measurement of spermatozoa on Gram stain, and (iv) self-reported sexual intercourse in the past 2 days. Sensitivity and specificity were calculated for each technique in comparison with PSA levels. Results A total of 119 (39.4%) women had a detectable PSA. Compared with measurable PSA, the sensitivity and specificity for other methods were: acid phosphatase (26.9%, 98.4%), Gram stain (36.1%, 98.4%), and self-report of intercourse in the past 48 hr (41.9%, 88.8%). Conclusion Compared with PSA levels, commonly used assays for recent semen exposure are inaccurate. This inaccuracy may affect the results of studies, which measure vaginal immune factors like cytokines or retrieve DNA from vaginal specimens.