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Nexplanon is a single-rod contraceptive implant that should be placed subdermally at the inner side of the upper nondominant arm approximately 8-10 cm above the medial epicondyle of the humerus. Insertion guidelines were recently updated to place of insertion superficial of the triceps muscle to lower risk of insertion into vessels and nerves. If migration however occurs, it is most commonly around the insertion site. Migration above 2 cm is rarely reported [Ismail H, Mansour D, Singh M. Migration of implanon®. BMJ Sexual Reproduct Health. 2006;32:157-159]. This is a case report of a 24-year-old caucasian woman who presented with an impalpable Nexplanon implant that was, with the help of chest radiography and CT, located in a posterior basal subsegmental pulmonary artery in the left lower lobe of the lung. An attempt to remove the contraceptive implant by endovascular approach was unsuccessful. The implant remains in situ . Etonogestrel and oestradiol concentrations were followed over time.

Background: Oral contraceptive use has been associated with a higher breast cancer risk; however, evidence for the associations between different oral contraceptive formulations and breast cancer risk, especially by disease subtype, is limited., Objective: This study aimed to evaluate the associations between oral contraceptive use by formulation and breast cancer risk by disease subtype., Study Design: This prospective cohort study included 113,187 women from the Nurses' Health Study II with recalled information on oral contraceptive usage from 13 years of age to baseline (1989) and updated data on usage until 2009 collected via biennial questionnaires. A total of 5799 breast cancer cases were identified until the end of 2017. Multivariable Cox proportional hazards models estimated hazard ratios and 95% confidence intervals for the associations between oral contraceptive use and breast cancer risk overall and by estrogen and progesterone receptor and human epidermal growth factor receptor 2 status. Oral contraceptive use was evaluated by status of use (current, former, and never), duration of and time since last use independently and cross-classified, and formulation (ie, estrogen and progestin type)., Results: Current oral contraceptive use was associated with a higher risk for invasive breast cancer (hazard ratio, 1.31; 95% confidence interval, 1.09-1.58) when compared with never use, with stronger associations observed for longer durations of current use (>5 years: hazard ratio, 1.56; 95% confidence interval, 1.23-1.99; ≤5 years: hazard ratio, 1.19; 95% confidence interval, 0.95-1.49). Among former users with >5 years since cessation, the risk was similar to that of never users (eg, >5 to 10 years since cessation: hazard ratio, 0.99; 95% confidence interval, 0.88-1.11). Associations did not differ significantly by tumor subtype. In analyses by formulation, current use of formulations containing levonorgestrel in triphasic (hazard ratio, 2.83; 95% confidence interval, 1.98-4.03) and extended cycle regimens (hazard ratio, 3.49; 95% confidence interval, 1.28-9.53) and norgestrel in monophasic regimens (hazard ratio, 1.91; 95% confidence interval, 1.19-3.06), all combined with ethinyl estradiol, was associated with a higher breast cancer risk when compared with never oral contraceptive use. No association was observed for current use of the other progestin types evaluated (norethindrone, norethindrone acetate, ethynodiol diacetate, desogestrel, norgestimate, and drospirenone), however, sample sizes were relatively small for some of the subgroups, limiting these analyses., Conclusion: Current oral contraceptive use was associated with a higher risk for invasive breast cancer regardless of disease subtype, however, the risk in former users was comparable with never users 5 years after cessation. In analyses by progestin type, associations were observed for select formulations containing levonorgestrel and norgestrel. Assessment of the associations for newer progestin types (desogestrel, norgestimate, drospirenone) was limited by sample size, and further research on more recently introduced progestins is warranted., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Abstract: The simplicity, sensitivity and expeditiousness of ion mobility spectrometry (IMS) make it especially useful for the determination of active principal ingredients (APIs) present at low concentrations in pharmaceuticals. However, the poor resolution of this technique precludes the identification and/or determination of substances with similar molecular weights, which exhibit also similar drift times and give overlapped peaks as a result. Oral contraceptives are pharmaceutical formulations containing two APIs of similar molecular weights at very low concentrations which therefore give strongly overlapped peaks hindering their determination by IMS. In this work, we assessed the potential of IMS for detecting and quantifying the contraceptives ethinylestradiol (ETE) and desogestrel (DES) in commercial tablets. To this end, we used various chemometric techniques including a second-derivative (TN2D) algorithm and the more powerful choice Multivariate Curve Resolution (MCR) to improve the resolution of IMS and enable the determination of both APIs. Quantitation was based on PLS1 models for each API. The models constructed involve a single PLS factor with a Y-explained variance above 98.4%, obtaining a RMSEP of 0.34 and 0.63 for ETE and DES, respectively. The ensuing method, which was validated for use in routine analyses, is quite expeditious (analyses take less than 1min) and uses very small amounts of sample (a few microliters). Based on the results, IMS has a great potential for the qualitative and quantitative determination of APIs in low doses. [Copyright &y& Elsevier]

Despite the increase in the substitution of branded medicinal product with generic drugs, this is a controversial issue for some pharmacological groups (such as contraceptives). The aim of the present clinical trial was to assess the bioequivalence and tolerability of two oral formulations of desogestrel. Thirty-three healthy female volunteers participated in this randomized and two-way crossover study. During two separate experimental periods, with at least four weeks of washout period, women received a single oral dose of 75 μg of desogestrel from each of the formulations (test formulation and reference formulation). Desogestrel bioavailability was determined by the measurement of 3-ketodesogestrel plasma concentration. Pharmacokinetic parameters were comparable and the 90% CI for the ratio of Cmax (96.14-114.53%) and AUC0-t (105.73-123.83%) values for the test and reference formulations fell within the established regulatory interval (80-125%). Both formulations were also comparable in terms of tolerability. From the results of this study it can be concluded that test formulation (desogestrel 75 μg, Cyndea PHARMA S.L.) is bioequivalent to the reference formulation (Cerazet® 75 μg, Organon Española S.A.). [ABSTRACT FROM AUTHOR]

Objective A systematic review of studies published between January 1995 and April 2010 aimed at determining the effect of combined hormonal contraceptives (CHCs), administered orally, transdermally or vaginally, on the risk of venous thromboembolism (VTE). Results Of the 625 potentially eligible references reviewed, 25 studies meeting the inclusion and exclusion criteria were entered in the meta-analysis. The pooled relative risks of VTE associated with the various CHCs, depending on their progestogen, were: gestodene vs. levonorgestrel 1.33 (95% confidence interval [CI]: 1.08-1.63); desogestrel vs. levonorgestrel 1.93 (95% CI: 1.31-2.83); and drospirenone vs. levonorgestrel 1.67 (95% CI: 1.10-2.55). The pooled adjusted odds ratio for norgestimate vs. levonorgestrel was 1.11 (95% CI: 0.84-1.46) and that for cyproterone acetate vs. levonorgestrel 1.65 (95% CI: 1.30-2.11). Conclusions The safest CHCs in terms of VTE are those containing levonorgestrel or norgestimate. The risk of VTE associated with desogestrel-, drospirenone- or cyproterone acetate-containing CHCs is greater than that associated with CHCs containing levonorgestrel. The increased risk of VTE found for CHCs with gestodene compared to CHCs with levonorgestrel seems smaller than in previous analyses. There were no differences in VTE risk between oral and transdermal CHCs containing norgestimate or norelgestromin, respectively. [ABSTRACT FROM AUTHOR]

Objective. Recently, we found decreased levels of C-reactive protein (CRP) during use of the low-dosed contraceptive implant Implanon®. To further elucidate, whether this finding might be a sign for a lower inflammatory reaction and is associated with changes in levels of other cytokines, we investigated the effect of this implant on interleukin-6 (IL-6) and adiponectin. Plasma lipids and sex hormone levels have been shown to interact with the investigated parameters in vivo and in vitro. Therefore these parameters were measured as well. Design. Prospective case-control study. Setting. Family-planning centre, University hospital. Subjects. Thirty-six non-smoking women with regular cycles. Interventions. Blood samples for the measurements were taken in the early follicular phase of the cycle in both groups. A second sample was taken 12 weeks after Implanon insertion or in the controls during the early follicular phase of cycle 4. Results. Implanon did not cause significant changes in IL-6, adiponectin or lipoprotein (Lp)(a). At baseline, there was a significant positive correlation between IL-6 and CRP and a negative correlation between adiponectin and CRP. Conclusion. We did not observe a negative impact of Implanon on risk markers for atherosclerotic disease such as IL-6, adiponectin, and Lp(a). These data are reassuring for clinicians who prescribe progestagen-only preparations as first choice contraceptives in females with cardiovascular risk factors. [ABSTRACT FROM AUTHOR]

Abstract: Background: This in vitro study deals with the effect of a combination oral contraceptive steroid — desogestrel and ethinyl estradiol — on the expression of low-density lipoprotein receptor (LDLR) and its transcription factor (SREBP2) in assessing the functional effectiveness of the LDLR. Study design: Differentiated primary placental trophoblast cells isolated from term human placentae and cells from Jar cell line were used for the study. Low-density lipoprotein receptor and SREBP2 expressions were assessed by immunocytochemistry and immunoblot assays with and without combination contraceptive steroid challenge. Functional activity of LDLR was studied by rating the profile of cellular uptake of fluorescent Dil-LDL (1,1′-dioctadecyl-3,3,3′,3′-tetramethylindocarbocyanin perchlorate-LDL). Quantitation of Dil-LDL was done spectrofluorometrically. Results: Variation of concentration(s) of either of the components of a combination preparation (desogestrel and ethinyl estradiol) showed a comparable change in the expressions of LDLR and SREBP2 to attain their optimal levels. Maximum expression and a significant functional effectiveness were observed at a unique combination of desogestrel (20 ng/mL) and ethinyl estradiol (10 ng/mL). Conclusion: The stimulatory effect of a combination contraceptive steroid on LDLR expression is an associated phenomenon of the contraceptive-mediated stimulation of SREBP2 expression. [Copyright &y& Elsevier]

Purpose. The risk of venous thromboembolism (VTE) with drospirenone-containing oral contraceptives (OCs) is reviewed. Summary. Increasing attention and media have raised awareness and concern about whether drospirenone-containing OCs increase the risk of VTE. Two studies found that when compared with nonuse of OCs, use of drospirenone-containing OCs was associated with a fourfold to over sixfold increased risk of having a thrombotic event. One of these studies found an increased risk associated with short-term use of drospirenone-containing OCs; however, this study was limited by the small number of participants taking drospirenone despite the large number of study participants. The cohort study that found a higher rate of VTE among drospirenone users was only able to indicate an association between drospirenone use and VTE, not a cause-and-effect relationship. Three studies concluded that drospirenone-containing OCs did not appear to cause an increased risk of VTE. The hemostatic studies found no difference in the various variables assessed between drospirenone- and desogestrel-containing OCs or between cyclic and continuous administration of drospirenone-containing OCs. These results should be interpreted cautiously, as each study had limitations, such as not controlling for confounders (e.g., recent surgery, immobility, obesity), not providing p values to assess homogeneity between treatment groups, and not providing total numbers of participants or specific types of OCs. Patients who receive drospirenone-containing OCs should be educated regarding the signs and symptoms of VTE, along with an appropriate action plan. Conclusion. The majority of available data does not support the conclusion that drospirenone-containing OCs pose an increased risk of VTE compared with other OCs. [ABSTRACT FROM AUTHOR]

Abstract: Background: Migraine with aura (MA) is a contraindication to the use of combined oral contraceptives (COCs) because of the increased risk of ischemic stroke. Progestogen-only contraceptive pill (POP) is a safe alternative to COCs and it is preferable in women with cerebrovascular diseases or risk factors for stroke. Study Design: Prospective diary-based pilot study. Thirty women with MA (n=15 who have never used COCs and n=15 who had previously used COCs were diagnosed according to the International Headache Society criteria. The observational period lasted 9 months during which women filled in a diary with the clinical characteristics of headache attacks. After a 3-month run-in period, each subject received an estrogen-free desogestrel (DSG) (75 mcg/day)-containing OC (Cerazette®; Schering-Plough, formerly NV Organon, Oss, The Netherlands). Follow-up evaluations were planned at the end of the third and sixth month of treatment. Results: The number (mean±S.D.) of migraine attacks was significantly reduced both in previous COCs users (from 3.9±1.0 to 2.9±0.8; p<.001) and nonusers (from 3.2±0.9 to 2.6±1.3; p<.02) following 6 months of POP use in comparison with the run-in period. Duration of headache pain did not differ significantly in both groups throughout the study. Interestingly enough, a beneficial POP effect on the duration (mean±S.D.) of visual aura (from 16.3±9.5 to 11.4±5.6 min) and on the total duration (mean±S.D.) of neurological symptoms (from 33.6±23.3 to 18.6±18.0 min) was only significantly reported by previous COCs users (p<.001, for both) by the end of the study period. The POP was well tolerated by each woman and the bleeding pattern was variable with a tendency towards infrequent bleeding. Conclusions: The present study supports the use of the POP containing desogestrel in a population of women with MA and underlines a positive effect on symptoms of aura, especially in MA sensitive to previous use of COCs. [Copyright &y& Elsevier]

Objective. The aim of this study was to investigate the effects of two currently used low-dose combined oral contraceptives (COCs) (20μμg ethinyl estradiol [EE]/150μμg desogestrel [DSG] vs. 20μμg EE/100μμg levonorgestrel [LNG]) on plasma homocysteine levels. Methods. A total of 90 participants were enrolled in the study; 30 of them had not been using COC for at least 12 months prior to their enrollment, while 60 were on regular treatment within 12--18 months. Therefore, the control group consisted of 30 participants. Group DSG/EE consisted of 30 women and group LNG/EE consisted of 30 women. Serum samples of homocysteine profile were obtained during the early follicular phase. Results. Significantly lower serum homocysteine concentrations (Group DSG/EE: 7.2 ±± 1.3; Group LNG/EE: 9.1 ±± 3.2; Control group: 8.2 ±± 2.2; p < 0.05) were observed in DSG/EE group compared to LNG/EE and control groups. Conclusion. Although the decrease in homocsyteine levels with 20μμg EE/150μμg DSG containing COC was statistically significant, the clinical relevance of our findings needs to be further investigated. [ABSTRACT FROM AUTHOR]

Abstract: Background: A prospective randomized trial was conducted to compare efficacy of a drospirenone-containing combined oral contraceptives (COC) with desogestrel-containing COC in women with polycystic ovary-syndrome (PCOS) not desirous of child-bearing. Study Design: Sixty women were randomized into study group [ethinylestradiol (EE) 30 mcg+drospirenone 3 mg] and control group (EE 30 mcg+desogestrel 150 mcg), treated for 6 months and followed up at 1 month, 3 months, 6 months, during treatment and 3 and 6 months post-treatment. Acne and hirsutism scoring, bodyweight, body mass index (BMI), blood pressure (BP), ultrasound parameters, lipid profile, glycemic profile and hormonal profile were compared. Results: Cycles were regular in both groups during treatment. Effect of regular cycles persisted in 44.83% (13/30) vs. 17.24% (5/30) in study vs. control group at 6 months post-treatment with 33.3% decreased hirsutism score in the study group (versus no change in control group) even at 6 months after stopping treatment. With treatment, BMI fell by 0.52 kg/m2 in the study group; systolic and diastolic BP fell in the study group while it rose in the control group. Low-density lipoprotein significantly decreased and high-density lipoprotein was elevated in the study group (p<.05). The study group showed a significant fall in fasting/postprandial blood sugar and insulin and total testosterone against a rise in the control group. Conclusion: In women with PCOS, a drospirenone containing COC has better outcome in terms of persistent regular cycles, antiandrogenic effect, fall in BMI and BP, better lipid profile, favorable glycemic and hormonal profile than desogestrel-containing COC. [Copyright &y& Elsevier]

The efficient synthesis of natural products, drugs, and materials with economical and ecological advantages is a very important goal in modern synthetic chemistry. In such an approach, toxic substrates as well as reagents have to be avoided, the amount of waste has to be reduced, and the exploitation of our resources has to be diminished. In this respect, the use of catalytic processes is highly advantageous; however, even more beneficial is the combination of several catalytic processes either in a sequential or, more efficiently, in a domino mode. In this article, the synthesis of several natural products, drugs, and materials is described, employing multiple Pd-catalyzed processes either in a sequential or a domino fashion. Based on a double-Heck reaction developed by us for the preparation of estradiol, the efficient synthesis of the highly potent contraceptive desogestrel is discussed; for the synthesis of α-tocopherol and diversonol an enantioselective domino-Wacker/Heck reaction was utilized, whereas in the case of diversonol, a domino-Wacker/carbonylation was even more effective, and several molecular switches containing a helical tetrasubstituted double bond were prepared employing a domino-carbopalladation/Stille reaction. Finally, acenaphthylenes could be obtained by a domino-carbopalladation/C-H-activation. [ABSTRACT FROM AUTHOR]

Abstract: Background: The study was conducted to investigate whether hormonal contraceptives administered via the oral and vaginal route exert a similar effect on insulin sensitivity (SI). Study Design: This is a prospective, randomized study performed in the University Hospital. Subjects were healthy lean young women, needing a hormonal contraceptive, randomly allocated to receive for 6 months (a) an oral contraceptive (OC) containing 30 mcg ethinylestradiol (EE)/150 mcg desogestrel (DSG) (high-estrogen group; n=12), (b) an OC containing 20 mcg EE/150 mcg DSG (low-estrogen group; n=12) and (c) a vaginal ring contraceptive releasing, per day, 15 mcg EE/120 mcg etonorgestrel, the active DSG metabolite (n=12). SI and glucose utilization independent of insulin (Sg) were evaluated by the minimal model method. Modifications of total, high-density lipoprotein (HDL) and low-density lipoprotein cholesterol and triglycerides were also evaluated. Results: Sg did not vary with any treatment. SI decreased during OCs (5.74±0.49 vs. 3.86±0.44; p=.0005), independently of the high/low-estrogen dose. SI did not decrease during vaginal ring use (4.64±1.03 vs. 5.25±1.36; p=.57; p=.019 vs. oral). Total cholesterol and HDL cholesterol increased (p=.02) during OCs, independently of the dose. Triglycerides increased during both oral (p=.01) and vaginal (p=.032) contraceptive use. Conclusions: The present data indicate that in contrast to OC use, vaginal contraception with the ring does not deteriorate SI. The vaginal ring may represent an appropriate choice for long-term contraception in women at risk for developing diabetes mellitus or metabolic syndrome. [Copyright &y& Elsevier]

Objective: To present efficacy, safety, and bleeding profile results from the clinical trials that supported the U.S. Food and Drug Administration filing for the approval of a single-rod etonogestrel (ENG) contraceptive implant (Implanon). Design: Integrated analysis of 11 international clinical trials. Setting: Contraceptive clinics in U.S., Chile, Asia, and Europe. Patient(s): A total of 942 healthy women, aged 18 to 40 years. Intervention(s): Insertion of an ENG implant. Most women were enrolled in studies lasting either 2 or 3 years. Main Outcomes Measure(s): Efficacy was measured by the cumulative Pearl Index in women ≤35 years old. Safety was primarily assessed by incidence of adverse events. Bleeding profiles were analyzed via reference period analyses. Result(s): No pregnancies were reported while the ENG implants were in place. Six pregnancies occurred during the first 14 days after ENG implant removal. Including these six pregnancies, the cumulative Pearl Index was 0.38 (year 1 and 2 Pearl Indexes were 0.27 and 0.30, respectively). Common drug-related adverse events were headache, weight gain, acne, breast tenderness, emotional lability, and abdominal pain. Bleeding pattern changes were observed, but no one pattern predominated. Conclusion(s): The ENG implant is an efficacious and safe method of contraception which does not require patients'' consistent action. [Copyright &y& Elsevier]

Abstract: Background: Second-generation and third-generation oral contraceptives containing 30 mcg or more of ethinylestradiol (EE) decrease insulin sensitivity (SI). In this study, we investigated whether SI is decreased by contraceptives containing lower doses EE or by progestins with antiandrogenic properties. Study Design: Twenty-eight young healthy women were randomly allocated to receive 20 mcg of EE and 150 mcg of desogestrel (DSG) (n=14) or 30 mcg of EE and 2 mg of chlormadinone acetate (CMA) (n=14) for 6 months. SI and glucose utilization independent of insulin (Sg) were investigated by the minimal model method. Lipid modifications were also analyzed. Results: SI decreased with EE/DSG (7.09±1.4 vs. 4.30±0.91; p=.04; n=12), but not with EE/CMA (5.79±0.93 vs. 6.79±1.1; p=.48; n=12). SI modifications observed in the two groups were significantly different (−2.79±1.15 vs. 1.0±1.38; p=.05). Sg did not vary with either treatment. The response of C-peptide to glucose increased, but significantly so only with EE/CMA (p=.01). The C-peptide/insulin response increased with both EE/DSG (p=.05) and EE/CMA (p=.04). High-density lipoprotein (HDL) cholesterol (p=.02) and triglycerides (p=.02 and p=.01) increased in both groups, but HDL/low-density lipoprotein cholesterol (p=.02), apoprotein A1 (Apo-A1) (p=.04) and Apo-A1/apoprotein B (p=.048) increased significantly only with EE/CMA. Conclusions: The present study confirms that DSG, even when associated with low EE dose, decreases SI. By contrast, EE/CMA does not deteriorate SI and induces a favorable lipid profile. [Copyright &y& Elsevier]

Abstract: Background: This study was conducted to compare the effects of two monophasic oral contraceptives (OCs) containing ethinyl estradiol (EE) 30 mcg+either chlormadinone acetate (CMA) 2 mg (Belara®) or 0.15 mg desogestrel (Marvelon®) on lipid, hormone and other relevant metabolic parameters. Study design: Markers of lipid and carbohydrate metabolism, and reproductive hormone levels, were measured in 45 subjects randomly assigned to 6 months of treatment with one of the two OCs. The cortisol response to adrenocorticotrophic hormone (ACTH) stimulation was also evaluated. Results: In both treatment groups, triglycerides, high-density lipoprotein cholesterol (HDL-C), apolipoprotein (Apo) AI and Apo AII levels increased; low-density lipoprotein cholesterol (LDL-C) and the LDL-C/HDL-C ratio decreased; and total cholesterol and lipoprotein(a) were unchanged during treatment. Effects on HDL-C, Apo AI, LDL-C and the LDL-C/HDL-C ratio were more evident in the EE 30 mcg+CMA 2 mg group. Follicle-stimulating hormone, luteinizing hormone and androgen levels decreased and sex hormone-binding globulin levels increased in both groups. Both OCs increased basal cortisol levels and cortisol response to ACTH. Oral contraceptive did not have a clinically significant impact on carbohydrate metabolism. Conclusions: Both low-dose monophasic OCs had comparable effects on lipid, hormone and metabolic parameters during six cycles of treatment in healthy female subjects. There was some evidence of a beneficial effect on atherogenic cardiovascular risk markers, which was slightly more pronounced with EE 30 mcg+CMA 2 mg. [Copyright &y& Elsevier]

Objective: To assess the side effects and the continuation rate of combined oral contraceptive (COC) containing desogestrel (Marvelon®) during 12 months. Methods: This was a post-marketing surveillance study on Marvelon® COC among 870 healthy rural women in 5 different counties of Jiangsu Province during 12 months. Results: About 24.02% of the women who used Marvelon® COC experienced side effects during 12 months. Gastrointestinal disorder, bleeding/spotting and chloasma were ranked the first three in the side effects. The rate of side effects of Marvelon® COC users during the first 3 months in southern area of Jiangsu was significantly higher than that of users in northern area of Jiangsu. Most of the users did not experience obvious weight changes i.e., loss or increase in weight of more than 5 kg during 12 months. Blood pressure and biochemical indicators of almost 99% among users were within the normal range. The gross cumulative continuation rate for 12 months was 83.14%; the most common medical reason for discontinuation was gastrointestinal disorder. There was an increased risk of discontinuation use among women with lower educational level. Conclusion: Marvelon® COC brought fewer side effects and was well accepted when applied in Chinese rural women. [Copyright &y& Elsevier]

Aims: To show the efficacy of oral contraceptive (OC) treatment for hospitalized adolescent patients with abnormal uterine bleeding (AUB). Materials and Methods: Thirty-one girls with AUB and anemia hospitalized within the last two years were included. The patients' medical records were evaluated retrospectively. All patients were given combined OC containing 0.03 mg ethinyl estradiol plus 0.15 mg desogestrel according to a defined protocol. Results: Among 31 patients, 8 (25.8%) had bleeding disorders: 3 (9.7%) had factor VII deficiency, 3 (9.7%) thrombocytopenia, 1 (3.2%) factor VIII deficiency and 1 (3.2%) von Willebrand disease. Vaginal bleeding stopped in all patients within a few days with the treatment protocol. Conclusions: Adolescents are good responders to medical treatment despite the presence of bleeding disorders, probably due to the positive coagulative effect of the estrogen component of OCs on platelets and clotting factors. Continuation of OC will be a problem in adolescent girls, because there are some misconceptions about OC in the Turkish population, such as that OC can cause infertility or hormonal imbalance. Appropriate counselling is necessary to overcome this difficulty. We believe that the presence of an Adolescent Gynecology Unit affected the success of our treatment. [ABSTRACT FROM AUTHOR]

Background and methodology Combined oral contraceptives (COCs) provide reliable and convenient contraception, although contraindications and tolerability issues may limit their use in some women. Progestogen-only pills (POPs) may be more suitable for some women, however, traditional POPs do not have the same contraceptive efficacy as COCs. A literature search was performed in order to assess the incidence of ovulation with available COCs, traditional POPs and with a desogestrel POP [Cerazette, 75 μg desogestrel (DSG)]. The following databases were searched: MEDLINE, EMBASE, Biosis, Derwent Drug File, Current Contents and the in-house Organon database ‘Docs’ (which contains all published reports of Organon products). Searches used free-text terms [e.g. Contraceptive$ in combination with (Ovulat$ adj Rate$), (Ovar$ adj Activ$) or (Escap$ adj Ovulat$)] and were limited to the search criteria ‘Human’ and ‘from 1979 onwards’. The searches included publications up to July 2008. Results Many of the studies were hampered by inadequate ovulation criteria; however, the overall incidence of ovulation determined by the reports uncovered in the literature search was 2.0% [95% confidence interval (CI) 1.1–3.3] with COCs containing 30–35 μg ethinylestradiol (EE), 1.1% (95% CI 0.60–2.0) with 15–20 μg EE COCs, 4.6% (95% CI 2.8–6.9) with phasic COCs, 1.25% (95% CI 0.03-6.8) with Cerazette and 42.6% (95% CI 33.4–52.2) with traditional POPs. Conclusions The findings indicate that COCs and the desogestrel POP are equally effective in suppressing ovulation, whilst the traditional POP formulations are less effective. [ABSTRACT FROM PUBLISHER]

Abstract: Background: The study was conducted to evaluate the efficacy and safety for the prevention of pregnancy of a 28-day oral contraceptive (OC) containing 150 mcg desogestrel (DSG)/20 mcg ethinyl estradiol (EE) for 21 days followed by 7 days of 10 mcg EE (Cette-28). Study Design: A 6-month, prospective, multicenter, single-arm study was conducted in 1302 women aged 18–45 years. Results: Over six cycles of treatment, the cumulative risk of pregnancy among all treated subjects (n=1262) was 0.9%. The Pearl Index for women 18–35 years of age (n=1042) was 2.20, including 9 pregnancies with estimated conception dates during active drug ingestion or up to 7 days after the last combination tablet. The rate of unscheduled bleeding was low and the duration of scheduled bleeding was approximately 2 days during each of the six treatment cycles. The safety profile was similar to what has been reported for other OCs. Conclusion: This low-dose, 28-day OC incorporating 7 days of 10 mcg EE during the hormone free interval is effective and safe for the prevention of pregnancy and is well-tolerated by women. [Copyright &y& Elsevier]

Objectives To evaluate the effects of an oestrogen-free oral contraceptive (Cerazette®; 75 mcg/day desogestrel) in women with oestrogen-related symptoms during previous combined oral contraceptive (COC) use (ERS study) and in women with dysmenorrhoea (DYS study). Methods Two similarly designed prospective, non-comparative multicentre observational studies were carried out in Germany. Altogether, 403 women with oestrogen-related symptoms during previous COC use and 406 women with dysmenorrhoea took Cerazette® continuously. Symptom-related assessments were made at baseline and after 3-4 months, along with bleeding pattern and treatment satisfaction. Results In the ERS study, the four oestrogen-related symptoms studied resolved or improved in over 70% of women. Nausea improved/resolved most (92% of women), followed by breast tenderness (90%), oestrogen-related headache (84%) and oedema (74%). In the DYS study, dysmenorrhoea resolved or considerably improved in 93% of the study population. Correspondingly, use of analgesics dropped from 70% of women at baseline to 8% at study end. Adverse events were reported by 7-8% of both study populations and were mainly bleeding irregularities. Most women in both studies were satisfied with treatment (∼90%) and wished to continue treatment after study completion (∼85%). Conclusions Cerazette® in this study set-up improved oestrogen-related symptoms and dysmenorrhoea in women affected and treatment was well accepted. [ABSTRACT FROM AUTHOR]

Abstract: Background: The aim of this study was to compare in vitro the role of two oral contraceptives, desogestrel (a less androgenic derivative of levonorgestrel) and levonorgestrel — alone and in combination with ethinyl estradiol — on low-density lipoprotein (LDL) receptor regulation by assessing receptor protein expression and functional effectiveness. Study Design: Placental tissue and cultured placental cells (JEG-3) were used to study the expression and endocytotic activity of LDL receptor protein. The expression of the receptor was assessed by immunocytochemistry and immunoblot assays with and without contraceptive challenge. Functioning activity of LDL receptor was studied by measuring the rate of uptake of LDL by placental cells. Quantification of LDL was based on the total cholesterol content of the lipoprotein. Results: A combination of desogestrel (20 ng/mL of incubation medium) and ethinyl estradiol (10 ng/mL of incubation medium) maintained the LDL receptor at high level of expression and functioning mode. In contrast, the double-blind preparation of levonorgestrel (20 ng/mL) and ethinyl estradiol (10 ng/mL) had shown much lower expression as well as receptor-mediated LDL uptake. The concentration of contraceptives used in this study was similar to the prevailing concentration of oral contraceptives in clinical use. Conclusion: Higher expression of LDL receptor and enhanced rate of LDL uptake by the receptor protein projects the possibility that there might be less atherosclerosis-related disorders from the combination of desogestrol and ethinyl estradiol. [Copyright &y& Elsevier]

Objective: To evaluate the effects after 10 days of an original treatment combining oral progestins with vaginal raloxifene to maximize the antiproliferative effect on the endometrium. Design: Prospective, randomized, clinical pilot study. Setting: Academic research environment. Patient(s): Ninety women with endometrial polyps. Intervention(s): On day 1 of the subsequent menstrual cycle, patients were randomized to receive oral desogestrel (n = 30) for 10 days combined with a tablet of raloxifene (60 mg) per vaginam (group A); oral desogestrel at 60 mg/day (n = 30; group B); or oral danazol at 200 mg, three times a day (n = 30; group C). Main Outcome Measure(s): Ultrasound measurement of endometrial thickness on day 11 of both the pretreatment and treatment cycles, surgeon satisfaction (0 to 10, visual analogue scale), and side effects. Result(s): At the second evaluation, the mean percentage reduction in endometrial thickness in group A was statistically significantly greater than in the other groups. Surgeon satisfaction in terms of endometrial thinning was also greater with group A. Conclusion(s): Oral desogestrel plus vaginal raloxifene provides a fast, low-cost, and satisfactory preparation of the endometrium for operative hysteroscopy. [Copyright &y& Elsevier]

Abstract: A fast and highly sensitive high performance liquid chromatographic/ion-trap mass spectrometric method (LC/MS) has been developed for simultaneous determination of ethynylestradiol (EE2), gestodene (GES), levonorgestrel (LNG), cyproterone acetate (CPA) and desogestrel (DES). Among three types of sorbents tested (C8, C18 and phenyl) from two suppliers, the best separation was achieved on reverse phase Zorbax SB-Phenyl column using aqueous methanol as a mobile phase. A linear gradient profile from 70 up to 100% (v/v) in 7th min, kept constant at 100% up to 10th min and followed by a negative gradient to 70% of methanol up to 12th min was used for elution. Applicability of electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) and influence of the mobile phase composition, its flow rate, capillary/vaporizer temperature of API source and in-source fragmentor voltage ionization are discussed. The on-column limits of quantification (10S/N) were 300pg of EE2, 14pg of GES and LNG, 4pg of CPA and 960pg of DES per injection (1μL) using APCI with data collection in selected ion monitoring (SIM) mode. The analytical performance of the method was evaluated using the determination of EE2, GES, LNG, CPA and DES in contraceptives and river water samples. [Copyright &y& Elsevier]

Background: Implanon is the trade name for a contraceptive implant that releases etonogestrel over a 3-year period. The rod is inserted into the subdermis of the upper arm. The implant should be palpable and easily removed through a small incision. Aims: To determine whether ultrasound is an accurate means of localising and guiding removal of non-palpable Implanon implants. Methods: All patients referred to The Northern Hospital, between March 2002 and October 2005, for localisation and/or removal of their non-palpable Implanon implants were included in this study. Ultrasound was used to locate the implants, the implant was considered localised when a linear echogenic rod with posterior acoustic shadowing was identified. When removal of the implant was requested and the implant was clear of neurovascular structures, blunt dissection was performed under ultrasound control and the implant was extracted. If the implant was considered too close to major neurovascular structures, the position of the implant was marked and the patient was referred for surgical removal. Results: Thirty-four women were included in the study. In 33 patients the implant was identified. In one patient no implant was found and its absence was confirmed by serum assay. Twenty-four patients were referred for implant removal. In 20 patients the implant was successfully removed under ultrasound guidance. In the other four patients the implant was close to neurovascular structures. The position of the implants was marked and surgical removal was successfully performed. Conclusion: Ultrasound is highly accurate at localising and guiding removal of non-palpable Implanon implants. [ABSTRACT FROM AUTHOR]

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Abstract: Purpose: This study was conducted to evaluate the effects of two different oral contraceptives (OCs) on homocysteine (Hcy) metabolism in 20 women with polycystic ovary syndrome (PCOS). Methods: Women were randomly allocated to receive either the biphasic OC containing 40/30 μg ethynylestradiol (EE)+25/125 μg desogestrel (DSG; n=10) or the monophasic OC containing 35 μg EE and 2 mg cyproterone acetate (CPA; n=10). Investigations were performed before and after 6 months of treatment. Fasting vitamin B12, folate, Hcy and insulin sensitivity (SI), and glucose utilization independent of insulin (Sg), by the minimal model method, were evaluated. Results: Folate and vitamin B12 were not significantly modified by either OC. EE/DSG decreased SI (2.53±0.35 vs. 1.68±0.45; p<.05), without modifying Hcy (9.54±0.7 μmol/L vs. 9.18±0.6 μmol/L). EE/CPA improved SI (1.47±0.38 vs. 3.27±0.48; p<.04) and decreased Hcy (9.8±1.9 μmol/L vs. 7.9±0.9 μmol/L; p<.05). This study indicates that in women with PCOS, EE/CPA, but not EE/DSG, improves IS and decreases fasting Hcy. [Copyright &y& Elsevier]

Abstract: Purpose: In this open-label, randomized study, we assessed the effects on hemostasis of two combined oral contraceptives containing drospirenone (DRSP) as progestogen component. Methods: Three milligrams of DRSP, a progestogen with antimineralocorticoid activity, was combined with either 30 or 20 μg ethinyl estradiol (EE) (DRSP/30EE; DRSP/20EE) and compared with a preparation containing 150 μg desogestrel (DSG) and 30 μg ethinyl estradiol (DSG/30EE). A total of 75 healthy female volunteers aged 18–35 years were enrolled. The hemostasis variables were measured in the medication-free precycle (baseline); in the first, third and sixth treatment cycle; and in the follow-up phase. The target variables for comparison were the relative changes from baseline to Cycle 6. Results: Data of 25 volunteers in each group were valid for the per-protocol evaluation. Most changes in hemostasis variables were similar in the three treatment groups. All procoagulatory variables and the anticoagulatory variable protein C antigen increased slightly, while protein S antigen and activity decreased. For fibrinogen and protein S activity, the changes were statistically significant: less pronounced with DRSP/20EE compared to DSG/30EE at Cycle 6. There were no statistically significant differences in the changes of antifibrinolytic variables, the global clotting tests and D-dimer. All pairwise comparisons of DRSP/30EE vs. DSG/30EE yielded nonsignificant results; however, there was a trend of a lower impact of DRSP/20EE on nearly all hemostatic parameters compared to the 30EE products. All three study treatments were safe and well tolerated by the volunteers and provided adequate contraceptive reliability. Conclusion: The changes in the hemostatic variables for DRSP/20EE were less pronounced compared to DSG/30EE and DRSP/30EE. The results were in accordance with previous reports on effects of similar OCs. [Copyright &y& Elsevier]

Objective To investigate the effect of an oral contraceptive (Novial®) on facial seborrhea and moderate acne. Methods In this nonrandomized, group-comparative trial, women aged between 18 and 30 with seborrhea were enrolled. Women used either a phasic oral contraceptive containing ethinylestradiol (35/30/30 µg) and Desogestrel (50/100/150 µg (DSG-OC)) (n = 177) or no hormonal treatment (control group; n = 77) for four cycles. Results Overall, 161 subjects (90.9%) in the DSG-OC group and 73 subjects (94.4%) in the control group completed the study. In the DSG-OC group, the total score for sebum excretion decreased by 0.71 nL/cm 2 (95% CI 0.36–1.05). In the control group, sebum excretion increased by 0.05 nL/cm 2 (-0.55 to 0.46). The difference between groups (0.78 nL/cm 2 (0.19–1.36)) was statistically significant ( P = 0.010). The number of active follicles/cm 2 decreased by 0.86 (0.44–1.28) and 0.08 (-0.53 to 0.69), respectively ( P = 0.029). The difference in qualitative scores between the groups (0.93 (0.08–1.78)) was statistically significant ( P = 0.032). Overall, 19.3% of the subjects reported an AE (18.1% in the DSG-OC group, 22.1% in the control group). Conclusion Novial® effectively reduces seborrhea after only four cycles of treatment and may be a suitable oral contraceptive for women wishing to improve their facial skin condition. [ABSTRACT FROM AUTHOR]

Objective: To compare the effects of combined oral contraceptives (OCs) containing cyproterone acetate or desogestrel on insulin sensitivity in adolescents with polycystic ovary syndrome (PCOS). Design: A prospective randomized clinical trial. Setting: Outpatient gynecological clinic of Aretaieion University Hospital. Patient(s): Thirty-six adolescent girls with hyperandrogenism and six or less menses in the preceding 12 months. Intervention(s): Patients were separated in two groups: group A (n = 18) received 0.15 mg of desogestrel plus 0.030 mg of ethinyl E2 daily; and group B (n = 18) received 2 mg of cyproterone acetate plus 0.035 mg of ethinyl E2 daily, for 21 days followed by a 7-day rest, for 12 months. Main Outcome Measure(s): Hirsutism score, lipid, androgen, and sex hormone-binding globulin (SHBG) levels were evaluated at baseline. An oral glucose tolerance test (OGTT) was performed and metabolism indices, based on previously studied mathematical formulas, were assessed at baseline and at 12 months. Result(s): After 12 months of treatment, the homeostasis model assessment index of insulin resistance increased significantly in both groups. The fasting glucose-to-insulin ratio and predicted insulin sensitivity index decreased in group B. The delta of the area under the OGTT curve for insulin and predicted first and second phase insulin secretion indices increased significantly only in group B. Conclusion(s): We conclude that treatment of adolescent girls with PCOS with the two combined OCs administered, results in unfavorable changes of insulin sensitivity. In addition, cyproterone acetate is associated with an increase of insulin secretion and hyperinsulinemia. [Copyright &y& Elsevier]