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Background Materials and Methods Results Conclusions α‐1 blockers and dutasteride are widely used as agents to treat benign prostatic hyperplasia (BPH); the impact of these drugs on prostatic inflammation is still unclear. Herein, we investigated the impact of α‐1 blockers and dutasteride treatment of BPH in terms of the degree of prostatic inflammation.Tissue specimens were obtained from 143 BPH patients who were administered α‐1 blockers up until their operation. Thirty‐three of the patients had also been treated with dutasteride before the procedure. The degree of prostatic inflammation was quantified histologically by the ratio of high endothelial venule (HEV)‐like vessels. We divided this retrospective cohort into α‐1 blocker monotherapy and combination therapy (α‐1 blockers + dutasteride) groups and evaluated clinical parameters of the two groups in relation to the degree of chronic prostatic inflammation. At the same time, we assessed factors exacerbating chronic prostatic inflammation.Comparison of the monotherapy and combination therapy groups showed no significant differences in the parameters of the urodynamic study or degree of chronic prostatic inflammation, whereas the IPSS total score, voiding subscore, nocturia, intermittency, weak stream, and straining were significantly lower in the combination than the monotherapy group. The duration of α‐1 blockers administration was not correlated with the ratio of HEV‐like vessels, while that of dutasteride was strongly correlated (correlation coefficient = 0.595; p < 0.001). Multiple regression analysis demonstrated that the duration of dutasteride administration was a key factor exacerbating the degree of chronic prostatic inflammation.The present study showed that despite their ameliorating effect on prostatic hyperplasia, dutasteride contributed significantly to chronic prostatic inflammation. [ABSTRACT FROM AUTHOR]

Background: Salivary duct carcinoma (SDC) is a rare and aggressive subtype of salivary gland cancer, frequently associated with incurable recurrences and distant metastases (R/M). Proliferation of SDC relies on androgen receptor (AR) signalling, prompting the use of combined androgen blockade (CAB, i.e., luteinizing hormone-releasing hormone agonist and/or AR antagonists) to R/M SDC patients. However, only a subset of patients benefits from such treatments. We have shown that response to CAB is associated with steroid 5α-reductase 1 (SRD5A1) mRNA expression. SRD5A1 catalyses the intracellular conversion of testosterone into the more potent AR-agonist dihydrotestosterone. This conversion can be inhibited by dutasteride, a potent SRD5A1-inhibitor, which is currently prescribed for benign prostatic hyperplasia. We hypothesize that repurposing dutasteride to target AR signalling in SDC could enhance therapeutic response and clinical outcome in SDC patients. Methods: This prospective, open-label, randomized controlled phase II clinical trial, is designed to investigate whether dutasteride as an adjunct drug to CAB improves response rate and clinical outcome in patients with AR-positive R/M SDC. Patients are divided in two cohorts based on their prior systemic treatments. In cohort A, CAB-naïve patients (n = 74) will be randomly assigned to either a control arm (Arm 1) receiving CAB (goserelin 10.8 mg/3m and bicalutamide 50 mg/OD) or an experimental arm (Arm 2) where dutasteride (0.5 mg/OD) is added to the CAB regimen. In cohort B, patients with disease progression after adjuvant or first-line palliative CAB therapy (max. n = 24) will receive goserelin, bicalutamide, and dutasteride to assess whether the addition of dutasteride can overcome therapy resistance. The primary endpoints are the objective response rate and duration of response. Secondary endpoints are progression-free survival, overall survival, clinical benefit rate, quality of life, and safety. Translational research will be performed to explore molecular target expression differences and their correlation with clinical outcome. Discussion: The DUCT study addresses an unmet medical need by investigating the repurposing of dutasteride to enhance treatment response and improve clinical outcome for patients with R/M SDC, especially those with limited alternative treatment options, such as HER2-negative cases. By repurposing a registered low-cost drug, this trial's findings could be readily applied into clinical practice. Trial registration: Clinicaltrials.gov Identifier: NCT05513365. Date of registration: August 24, 2022. Protocol version: Current protocol version 4.0, February 21, 2024. [ABSTRACT FROM AUTHOR]

Abstract Background Salivary duct carcinoma (SDC) is a rare and aggressive subtype of salivary gland cancer, frequently associated with incurable recurrences and distant metastases (R/M). Proliferation of SDC relies on androgen receptor (AR) signalling, prompting the use of combined androgen blockade (CAB, i.e., luteinizing hormone-releasing hormone agonist and/or AR antagonists) to R/M SDC patients. However, only a subset of patients benefits from such treatments. We have shown that response to CAB is associated with steroid 5α-reductase 1 (SRD5A1) mRNA expression. SRD5A1 catalyses the intracellular conversion of testosterone into the more potent AR-agonist dihydrotestosterone. This conversion can be inhibited by dutasteride, a potent SRD5A1-inhibitor, which is currently prescribed for benign prostatic hyperplasia. We hypothesize that repurposing dutasteride to target AR signalling in SDC could enhance therapeutic response and clinical outcome in SDC patients. Methods This prospective, open-label, randomized controlled phase II clinical trial, is designed to investigate whether dutasteride as an adjunct drug to CAB improves response rate and clinical outcome in patients with AR-positive R/M SDC. Patients are divided in two cohorts based on their prior systemic treatments. In cohort A, CAB-naïve patients (n = 74) will be randomly assigned to either a control arm (Arm 1) receiving CAB (goserelin 10.8 mg/3m and bicalutamide 50 mg/OD) or an experimental arm (Arm 2) where dutasteride (0.5 mg/OD) is added to the CAB regimen. In cohort B, patients with disease progression after adjuvant or first-line palliative CAB therapy (max. n = 24) will receive goserelin, bicalutamide, and dutasteride to assess whether the addition of dutasteride can overcome therapy resistance. The primary endpoints are the objective response rate and duration of response. Secondary endpoints are progression-free survival, overall survival, clinical benefit rate, quality of life, and safety. Translational research will be performed to explore molecular target expression differences and their correlation with clinical outcome. Discussion The DUCT study addresses an unmet medical need by investigating the repurposing of dutasteride to enhance treatment response and improve clinical outcome for patients with R/M SDC, especially those with limited alternative treatment options, such as HER2-negative cases. By repurposing a registered low-cost drug, this trial’s findings could be readily applied into clinical practice. Trial registration Clinicaltrials.gov Identifier: NCT05513365. Date of registration: August 24, 2022. Protocol version Current protocol version 4.0, February 21, 2024.

Abstract Background Based on our observations at the largest outpatient urology clinic in Iran, patients for whom finasteride is prescribed as a secondary drug to tamsulosin tend to experience earlier and more severe sexual side effects without any difference in the amelioration of symptoms. This study aimed to compare the time lag, efficacy, and side effects of combination therapy with varying doses of dutasteride or finasteride added to tamsulosin for benign prostatic hyperplasia (BPH) treatment. Methods In this study 165 were randomized into 5 groups (each N = 33); receiving tamsulosin 0.4mg plus either of A: finasteride 3mg, B: placebo, C: dutasteride 0.25mg, D: finasteride 5mg or E: dutasteride 0.5mg. During the 6-month period of the study, International Prostate Symptom Score (IPSS), post-void residual urine (PVR), International Index of Erectile Function (IIEF-5), prostate volume (PV), prostate specific antigen (PSA) and maximum urinary flow rate (Qmax) were evaluated at baseline and at the 1st, 3rd and 6th month. The differences between each time point and baseline were then compared between groups. Results At 3-month follow-up, group E exhibited a higher decrease in PSA but a greater increase in Qmax compared to group A (p = 0.047 and 0.006, respectively). Group C showed higher Qmax increase compared to group A at 3 and 6 months (p = 0.003 and 0.014) and concurrently a more pronounced PV decrease at 1 and 3 months (p = 0.047 and 0.003, respectively). Group D had a significantly more decrease in their IIEF-5 compared to group A at one-month visit (p = 0.006). Conclusions In summary, at the sixth-month follow-up, dutasteride demonstrated superiority over finasteride solely in enhancing Qmax. Therefore, dutasteride may be marginally more beneficial as a secondary component of combination therapy in BPH. Trial registration IRCT, IRCT20120516009772N2. Registered 18 January 2021 Retrospectively registered, https://irct.behdasht.gov.ir/search/result?query=IRCT20120516009772N2 .

Androgenetic alopecia is the most common type of hair loss. Although the exact cause of this condition is not fully understood, it is known to involve excessive amounts of dihydrotestosterone. There are various treatment options available for androgenetic alopecia that aim to target these mechanisms. The FDA-approved therapies for this condition include topical minoxidil, oral finasteride, and low-level light therapy. This review will discuss the potential benefits of using spironolactone, dutasteride, and bicalutamide as alternative treatment options for androgenetic alopecia. [ABSTRACT FROM AUTHOR]

The most common type of alopecia in women is female androgenetic alopecia (FAGA), characterized by progressive hair loss in a patterned distribution. Many oral therapies, including spironolactone (an aldosterone antagonist), androgen receptor blockers (e.g., flutamide/bicalutamide), 5-alpha-reductase inhibitors (e.g., finasteride/dutasteride), and oral contraceptives, target the mechanism of androgen conversion and binding to its respective receptor and therefore could be administered for the treatment of FAGA. Despite significant advances in the oral treatment of FAGA, its management in patients with a history of gynecological malignancies, the most common cancers in women worldwide, may still be a concern. In this review, we focus on the safety of antiandrogens for the treatment of FAGA patients. For this purpose, a targeted literature review was conducted on PubMed, utilizing the relevant search terms. To sum up, spironolactone seems to be safe for the systemic treatment of FAGA, even in high-risk populations. However, a general uncertainty remains regarding the safety of other medications in patients with a history of gynecologic malignancies, and further studies are needed to evaluate their long-term safety in patients with FAGA and risk factors to establish an optimal risk assessment and treatment selection protocol. [ABSTRACT FROM AUTHOR]

Novel antifungal drugs are urgently needed to treat candidiasis caused by the emerging fungal multidrug-resistant pathogen Candida auris. In this study, the most cost-effective drug repurposing technology was adopted to identify an appropriate option among the 1615 clinically approved drugs with anti-C. auris activity. High-throughput virtual screening of 1,3-beta-glucanosyltransferase inhibitors was conducted, followed by an analysis of the stability of 1,3-beta-glucanosyltransferase drug complexes and 1,3-beta-glucanosyltransferase–dutasteride metabolite interactions and the confirmation of their activity in biofilm formation and planktonic growth. The analysis identified dutasteride, a drug with no prior antifungal indications, as a potential medication for anti-auris activity in seven clinical C. auris isolates from Saudi Arabian patients. Dutasteride was effective at inhibiting biofilm formation by C. auris while also causing a significant reduction in planktonic growth. Dutasteride treatment resulted in disruption of the cell membrane, the lysis of cells, and crushed surfaces on C. auris, and significant (p-value = 0.0057) shrinkage in the length of C. auris was noted at 100,000×. In conclusion, the use of repurposed dutasteride with anti-C. auris potential can enable rapid recovery in patients with difficult-to-treat candidiasis caused by C. auris and reduce the transmission of nosocomial infection. [ABSTRACT FROM AUTHOR]

LDOM has enhanced treatment options for female AGA, yet its combined efficacy with therapies such as spironolactone, finasteride, or dutasteride remains inadequately explored. This study aims to compare the efficacy and safety of LDOM in combination with spironolactone versus LDOM with finasteride or dutasteride in women with AGA. Our analysis revealed that both combination therapies produced similar improvements in hair growth and had comparable safety profiles. Although the LDOM with finasteride/dutasteride group showed a greater average increase in hair width and density, these differences were not statistically significant. These results endorse the use of LDOM in combination with either spironolactone or finasteride/dutasteride for female AGA, and underscore the necessity for further research to validate these findings and assess long-term treatment outcomes. [ABSTRACT FROM AUTHOR]

Context: Dutasteride is used in the treatment of benign prostate enlargement with reported many side effects. Aims: The purpose of this study is to examine how different doses of dutasteride (0.5 mg) in combination with tamsulosin affect the outcome of treatment of benign prostatic enlargement (BPE). Settings and Design: Prospective study (phase III trial). Subjects and Methods: Between April 2017 and March 2020, this randomized study was conducted on 300 patients with moderate-to-severe lower urinary tract symptoms attributable to BPE and a prostate volume of more than 40 cc. The patients were divided into three therapy groups at random (one-to-one randomization), each with 100 patients: (Group I) daily tamsulosin 0.4 mg plus dutasteride (0.5 mg). (Group II) every other day tamsulosin 0.4 mg plus dutasteride 0.5 mg. (Group III) once a week tamsulosin 0.4 mg plus dutasteride 0.5 mg. Statistical Analysis: Statistical analysis was carried out with the help of the SPSS program 22. (IBM, Armonk, NY, USA). The mean and standard deviation (SD) are used to express quantitative data (SD). When comparing two means, an independent-samples t-test of significance was used. To compare more than two means, a one-way analysis of variance was utilized. For multiple comparisons between distinct variables, a post hoc test was performed. Results: Patients were followed up every 3 months, with a 1-year follow-up to examine the medications’ efficacy, prostate size reduction, and erectile function. After 1 year of treatment, all groups showed significant improvement in their symptom scores. However, Groups I and II experienced a considerable reduction in prostate size after therapy, but Group III experienced no meaningful reduction. In terms of sexual dysfunction, there was a considerable shift in Group I after 12 months. Conclusions: Dutasteride treatment on the other day schedule has the same efficacy as the daily dose on prostate size at the same time; the other day scheduled dose has better preservation of sexual function.

Dutasteride 0.5 mg is a dual inhibitor of 5α‐reductase type I and II and was approved in Korea in 2009 for treating androgenetic alopecia (AGA) in men. We investigated the 5‐year efficacy and safety of dutasteride 0.5 mg in Korean men with AGA using the basic and specific (BASP) classification. This retrospective analysis included 99 male AGA patients aged ≥18 years who were treated with dutasteride 0.5 mg for at least 5 years from October 2009 to December 2016 at Kyung Hee University Hospital in Gangdong. Patient photographs were scored using the BASP classification, and the Investigator Global Assessment (IGA) was performed using a seven‐point scale. Patient improvement (IGA score ≥1) and prevention of disease progression (IGA score ≥0) were 89.9% (89/99) and 93.9% (93/99), respectively. According to the BASP classification, 52.5% (52/99) of the basic type, 75% (15/20) of the specific F type, and 82.2% (60/73) of the specific V type showed clinical improvement after 5 years of treatment. Dutasteride demonstrated long‐term safety and efficacy in Korean male patients with AGA over a period of at least 5 years, with results comparable to those of other long‐term efficacy studies of finasteride 1 mg in male patients with AGA. [ABSTRACT FROM AUTHOR]

Androgenetic alopecia is a common type of hair loss, which is generally influenced by genetic factors and systemic androgens resulting in follicular miniaturization. It can cause cosmetic problems leading to psychological distress among affected men and women. Effective standard medical treatments available are topical minoxidil 2 to 5%, oral finasteride, oral dutasteride, and hair transplantation. However, some patients do not achieve favorable results with standard treatments. For these reasons, other novel treatments have been developed, including new medications, regenerative medicines (autologous platelet-rich plasma, adipose-derived stem cells, micrograft generation, and exosome), and low-level laser therapy [ABSTRACT FROM AUTHOR]

Context: Dutasteride is used in the treatment of benign prostate enlargement with reported many side effects. Aims: The purpose of this study is to examine how different doses of dutasteride (0.5 mg) in combination with tamsulosin affect the outcome of treatment of benign prostatic enlargement (BPE). Settings and Design: Prospective study (phase III trial). Subjects and Methods: Between April 2017 and March 2020, this randomized study was conducted on 300 patients with moderate-to-severe lower urinary tract symptoms attributable to BPE and a prostate volume of more than 40 cc. The patients were divided into three therapy groups at random (one-to-one randomization), each with 100 patients: (Group I) daily tamsulosin 0.4 mg plus dutasteride (0.5 mg). (Group II) every other day tamsulosin 0.4 mg plus dutasteride 0.5 mg. (Group III) once a week tamsulosin 0.4 mg plus dutasteride 0.5 mg. Statistical Analysis: Statistical analysis was carried out with the help of the SPSS program 22. (IBM, Armonk, NY, USA). The mean and standard deviation (SD) are used to express quantitative data (SD). When comparing two means, an independent-samples t-test of significance was used. To compare more than two means, a one-way analysis of variance was utilized. For multiple comparisons between distinct variables, a post hoc test was performed. Results: Patients were followed up every 3 months, with a 1-year follow-up to examine the medications' efficacy, prostate size reduction, and erectile function. After 1 year of treatment, all groups showed significant improvement in their symptom scores. However, Groups I and II experienced a considerable reduction in prostate size after therapy, but Group III experienced no meaningful reduction. In terms of sexual dysfunction, there was a considerable shift in Group I after 12 months. Conclusions: Dutasteride treatment on the other day schedule has the same efficacy as the daily dose on prostate size at the same time; the other day scheduled dose has better preservation of sexual function. [ABSTRACT FROM AUTHOR]

Background: Dutasteride, is a drug whose mechanism of action is inhibition of the enzyme 5-alpha reductase. It has been approved for use in the treatment of benign prostatic hyperplasia. Dutasteride has low solubility and high permeability, which classifies it as Biopharmaceutics classification system class II, according to the Biopharmaceutics Classification System. It has a water solubility of only 0.038 ng/mL and a slow dissolving rate, resulting in its exclusive availability in the market as a formulation contained within soft gelatin capsules. Objective: The aim of this study involves two parts. First, is the enhancement of dutasteride dissolution rate, by the creation of dutasteride nanosuspension, and second is the enhancement of patient compliance by the transformation of this nanosuspension to oral fast-dissolving film, which is characterized by its fast disintegration, stability, and ease of administration. Methods: The solvent anti/solvent precipitation method was used to formulate dutasteride nanosuspension. In addition, dutasteride nanoparticles oral fast dissolving films were prepared by using the solvent casting method. To compare the in vitro release patterns of pure dutasteride film and selected dutasteride nanoparticles film, the statistical analysis for the dissolution investigation was conducted using the model-independent technique (employing similarity factor f2) utilizing a DD solver. The selected dutasteride nanoparticle film was supposed to be the test material, while the pure dutasteride film was supposed to serve as the reference. Results: dutasteride nanosuspension demonstrated a high enhancement of the dissolution rate. In addition, the prepared dutasteride nanoparticles oral fast-dissolving film exhibited a further increase in the rate of dissolution and fast disintegration, and the administration is easy, all of these properties making it a promising dosage form. Conclusion: Nanosuspension is an excellent approach for enhancing the solubility, dissolution rate, and effectiveness of drugs with limited aqueous solubility such as dutasteride. In addition, the oral fast-dissolving film can be considered a promising dosage form that will increase patient compliance due to its high dissolution rate, fast disintegration, and easy administration.

Concerns exist regarding the effects of 5-alpha reductase inhibitors (5-ARIs) on multipa-rametric magnetic resonance imaging (mpMRI) and clinically significant prostate cancer (csPCa) detection. Our objective is to analyze the effect of 5-ARI on the prostate imaging–reporting and data system (PI-RADS) distribution and csPCa and insignificant PCa (iPCa) detection. Among 2212 men with serum prostate-specific antigen levels of >3.0 ng/mL and/or suspicious digital rectal examinations who underwent mpMRI and targeted and/or systematic biopsies, 120 individuals exposed to 5-ARI treatment for over a year were identified. CsPCa was defined when the grade group (GG) was >2. The overall csPCa and iPCa detection rates were 44.6% and 18.8%, respectively. Since logistic regression revealed independent predictors of PCa, a randomized matched group of 236 individuals was selected for analysis. The PI-RADS distribution was comparable with 5-ARI exposure (p 0.685). The CsPCa detection rates in 5-ARI-naïve men and 5-ARI-exposed men were 52.6% and 47.4%, respectively (p 0.596). IPCa was detected in 37.6 and 62.5%, respectively (p 0.089). The tumor GG distribution based on 5-ARI exposure was similar (p 0.149) to the rates of csPCa and iPCa across the PI-RADS categories. We conclude that exposure to 5-ARI in suspected PCa men did not change the PI-RADS distribution and the csPCa and iPCa detection rates. [ABSTRACT FROM AUTHOR]

We aimed to determine the efficacy of the various available oral, topical, and procedural treatment options for hair loss in individuals with androgenic alopecia. Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review of the National Library of Medicine was performed. Overall, 141 unique studies met our inclusion criteria. We demonstrate that many over the counter (e.g. topical minoxidil, supplements, low-level light treatment), prescription (e.g. oral minoxidil, finasteride, dutasteride), and procedural (e.g. platelet-rich plasma, fractionated lasers, hair transplantation) treatments successfully promote hair growth, highlighting the superiority of a multifaceted and individualized approach to management. [ABSTRACT FROM AUTHOR]

Background: Minoxidil and the 5‐alpha reductase inhibitors (5‐ARIs), specifically, dutasteride and finasteride, are usually used to treat pattern hair loss (PHL), but evidence on the relative effectiveness of these drugs is far less for women than men. Aims: We performed an age‐adjusted network meta‐analysis (NMA) to determine the comparative efficacy of monotherapy with the three agents—in any dosage and administrative route—on PHL in adult women. Methods: The peer‐reviewed literature was systematically reviewed to obtain data for our NMA. The outcome measure for our NMA was "change in total hair density." We referred to "regimen" as an "agent and its dosage;" our Bayesian NMA estimated regimens' surface under the cumulative ranking curve (SUCRA) values and pairwise relative effects. Results: Our NMA used data from 13 trials—across which the following 10 regimens were identified (in decreasing order of SUCRA): 5 mg/day finasteride for 24 weeks (SUCRA = 95.7%), 5% topical minoxidil solution twice daily for 24 weeks (SUCRA = 89.5%), 1 mg/day minoxidil for 24 weeks (SUCRA = 78.1%), 5% topical minoxidil foam 1 half capful/day for 24 weeks (SUCRA = 66.5%), 3% topical minoxidil solution 1 mL twice daily for 24 weeks (SUCRA = 45.1%), 2% topical minoxidil solution 1 mL twice daily for 24 weeks (SUCRA = 44.6%), 5% topical minoxidil solution 1 mL/day for 24 weeks (SUCRA = 41.7%), 0.25 mg/day minoxidil for 24 weeks (SUCRA = 35.5%), 1.25 mg/day finasteride for 24 weeks (SUCRA = 24.8%) and 1 mg/day finasteride for 24 weeks (SUCRA = 4.3%). Conclusion: Our findings can improve clinical guidelines and help dermatologists manage female PHL more optimally with the available options. [ABSTRACT FROM AUTHOR]

Background Female pattern hair loss (FPHL) is a disease characterized by progressive hair thinning. Topical minoxidil is an FDA-approved drug for the treatment of androgenetic alopecia. Dutasteride (a 5a-reductase inhibitor) can also be used in a topical form to reduce its systemic side effects. Both agents can be used as mesotherapy after microneedling of the scalp to enhance their potency in the treatment of FPHL. Objective To compare the use of combined minoxidil and dutasteride versus dutasteride alone when applied topically after microneedling of the scalp in the treatment of FPHL. Patients and methods This study included 40 female patients with FPHL. Patients were divided into two groups: one group was treated with combined minoxidil 0.1% and dutasteride 0.01% with microneedling, and the other group received dutasteride 0.01% alone with microneedling. Trichoscopic evaluation was done. Results In a group A, who were treated with combined minoxidil and dutasteride, 4 patients (20%) had excellent improvement, 10 patients (50%) had a good response, 5 patients (25%) had a moderate response, and only 1 patient (5%) had no response, while in a group B, who treated with dutasteride, 1 patient (5%) had excellent improvement, 4 patients (20%) had a good response, 10 patients (50%) had a moderate response, and 5patients(25%) had no response, with a significant difference between both groups (P=0.033. There were the nonsignificant difference between both groups regarding trichoscopic findings before treatment, but after treatment, there was a significant difference between both groups concerning the mean percentage of the follicular unit with one hair and the number of patients who had vellus hairs in the dermoscopic field. Conclusion The combination of minoxidil 0.1% and dutasteride 0.01% after microneedling of the scalp was significantly more effective than dutasteride alone with microneedling for the treatment of FPHL. [ABSTRACT FROM AUTHOR]

The proposed HPLC Method was found to be simple, precise, accurate and economical for the estimation of dutasteride in Bulk and tablet dosage form. The present work, developed HPLC method was found suitable and validated. Luna - C-18 (250 mm x 4.6 mm, 20 µL) column was used for the assay. Mobile phase was Acetonitrile and Water in the ratio 80:20. Linearity was established in the range of 5-100 µg/ml with a coefficient correlation of 0.9998 and eluents were monitored at 242 nm and at 1 ml/min. flow rate. The Retention time was found to be 5.9 min. The efficiency of the column, expressed as the number of theoretical plates for six replicate injections was 11566 ± 119.695 (%CV1.03%) and USP tailing factor was 1.25 ± 0.012 (%CV 0.79). The regression equation for the calibration plot was Y = 0.0618 X - 0.008. Intra-day precision from 0.166 to 1.449 and Inter-day precision from 0.186 to 1.449. The% recovery of dutasteride from API and dosage form were 100.70% and 99.66%. The drug was subjected to stress conditions such as Oxidative and Photodegradation, Considerable degradation was found to occure in acidic and basic medium on heating at 100°C but no degradation was observed at room temperature. The drug was exposed to 10% H2O2{heating at 100°C forming degradation product at RT: 2.557}. The LOD and LOQ was 0.257µg and 0.779 µg respectively. When the flow rate was reduced, the retention time of dutasteride increased. The assay result with analyst #1 and Analyst #2 were % Assay = 98.40% (%RSD = 0.13%) and % Assay = 99.07% (%RSD =0.53) respectively. Robustness and ruggednesswasobserved that results were well within acceptance limits of 98-102%, with %RSD ±2.0%, indicating the method is rugged and provides consistent and reliable results which are not affected by small changes in experimental conditions. This method can be used for routine analysis of dutasteride. Running Title: A New Method Development and Validation of 5a-Reductase inhibitor using R-HPLC. [ABSTRACT FROM AUTHOR]

Nowadays androgenetic alopecia (AGA) has become a common concern of affected subjects of both sexes. Finasteride is approved by the Food and Drug Administration for the treatment of male AGA. There is no clear evidence to support the use of dutasteride in male AGA. In female AGA, the effectiveness of dutasteride and finasteride is still under debate, and there is no clear evidence to use any of them in female AGA. A systematic review was conducted to compare between dutasteride and finasteride in treating both male and female AGA, and their efficacy, safety, side effects with effective dosage. The review was done using several databases including: PubMed, Ovid Medline, Google Scholar, and Cochrane using the following search terms/keywords: "Dutasteride" AND "Finasteride" AND "Male pattern hair loss" AND "Female pattern hair loss" AND "Efficacy", "Tolerability" AND "Side effects" AND "Comparison". To search for articles related to efficacy, tolerability, side effects, used doses of dutasteride and finasteride in the treatment of male and female AGA. The review encompassed a total of nine studies. Four randomized controlled trials, one single-arm trial, two prospective cohorts, and two retrospective cohort studies. Seven studies exclusively enrolled male participants, while only two included female participants. All groups receiving various doses of dutasteride and finasteride exhibited a significant increase in hair count compared to the placebo group. Notably, dutasteride (0.5 mg) and dutasteride (2.5 mg) were significantly more effective than finasteride (1 mg) in increasing hair counts. Furthermore, no significant difference in adverse events was observed between finasteride and dutasteride. Dutasteride is more potent than finasteride in treating AGA in both males and females. All the adverse events between finasteride and dutasteride were comparable.