Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

Study Overview
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Brief Summary
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Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function as well as subject satisfaction with hair growth and quality of life in men with AGA. This study will consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks, and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of double-blind, placebo controlled treatment and 24 weeks of open-label treatment with dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a change in erectile function at the end of treatment.

Official Title
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A Prospective Study of Sexual Function in Men Taking Dutasteride for the Treatment of Androgenetic Alopecia

Conditions
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Alopecia

Intervention / Treatment
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* Drug: Dutasteride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject agrees to participate in the study and has signed and dated the informed consent form prior to the initiation of any study-related activities. AGA classified utilizing the Norwood-Hamilton classification. Men 18 to 50 years old, inclusively. Fluent and literate in local language with the ability to comprehend and record information on the International Index of Erectile Function, Hair Growth Satisfaction Scale, and DLQI questionnaires. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%). Have been in a stable heterosexual relationship during the last 6 months prior to screening and expect to maintain that relationship throughout the study. Must be sexually active: a man is considered sexually active if he has engaged in sexual intercourse (at least once) during the 4 weeks prior to screening. Men with a female partner of childbearing potential must agree to avoid exposure of his partner to semen by using a condom. Use of a condom must be from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e., a total of 4.5 months) to allow clearance of any residual drug in the semen after the last dose of study treatment. Willing to comply with study requirements. Exclusion Criteria: Current or pre-existing sexual dysfunction as determined by: History of erectile dysfunction defined as the consistent inability to achieve or maintain an erection sufficient to permit satisfactory sexual intercourse. Score of ≤25 on the erectile function domain (IIEF-EF) of the IIEF at screening or at the baseline visit. Evidence of hypogonadism. Have a communicable skin or sexually-transmitted disease, or any rash or lesions on the penis or in the surrounding area (as reported by subject and evaluated by investigator). Serum prostate-specific antigen (PSA) >2.0 ng/mL at screening. Serum creatinine >1.5xULN at screening. Unstable liver disease (chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria). History of malignancy (including prostate cancer) within the past 5 years, except basal cell or squamous cell carcinoma of the skin. History of prostate cancer before the age of 50 years in a first degree relative. History of breast cancer or clinical breast examination suggestive of malignancy. Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening; and uncontrolled diabetes or peptic ulcer disease that is uncontrolled by medical management. History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could, in the opinion of the investigator or the medical monitor, interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.Note: the investigator may consult with the GSK medical monitor if a condition could interfere with the subject's safety. Global scalp hair thinning, including occipital areas. Scarring of the scalp, including prior hair transplant or scalp reduction, or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., tinea infection, non-androgenetic-cause of alopecia, psoriatic dermatitis or other psoriatic lesions, or uncontrolled seborrheic dermatitis). History of hair transplantation at any time to correct AGA or use of hair weaving within 6 months prior to screening. History or evidence of hair loss other than AGA (e.g., due to an auto-immune, endocrine, mechanical or infectious process, or secondary to a scalp dermatological disorder). Use of any cosmetic product aimed at improving or correcting the signs of hair loss (e.g., scalp preparations with claims aiming at improved hair growth) within 2 weeks prior to screening. Use of light or laser treatments on the scalp (e.g., light emitting diode [LED] lamps) within 3 months prior to screening. Hypersensitivity to any 5-alpha reductase inhibitor (5-ARI) or its components or excipients or drugs chemically related to the study treatment. Use of dutasteride within 10 months prior to screening or use of finasteride within 6 months prior to screening. Previous use of systemic cytotoxic agents. Use of glucocorticoids (inhaled glucocorticoids are allowed; topical corticosteroids are allowed provided that they are not used on the scalp) within 3 months prior to screening. Use of the following prior to Baseline (within 1 week for topical products; within 1 week or 5 half-lives, whichever is longer, for systemic treatments): Phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); Minoxidil (oral or topical); Carpronium chloride; Systemic drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, and bicalutamide); Topical or systemic estrogen or progesterone; Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens); Drugs potentially causing hypertrichosis or telogen effluvium (e.g., valproic acid); Anabolic steroids; Participation in any study of an investigational or marketed drug (within 5 half lives of drug) or device that may affect hair growth or sexual function prior to screening for this study. Note: Subject must not participate in any other drug or device studies during the course of this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dutasteride Arm<br>Subjects will receive dutasteride 0.5 milligrams (mg) administered orally once daily for 24 Weeks | Drug: Dutasteride<br>* Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally.<br>|
| Placebo Comparator: Placebo Arm<br>Subjects will receive placebo administered orally once daily for 24 Weeks | Drug: Placebo<br>* Dutasteride matching placebo will be supplied as capsules to be administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. | 24 weeks | 
| Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. | 24 weeks | 
| Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | Clinical chemistry parameters included: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | Clinical chemistry parameters included: ALT, ALP, AST, and GGT at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Incidence of Premature Discontinuations in the Double-blind Treatment Period | Participants were referred as premature discontinuations if they do not complete the double-blind period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants. | Week 24 | 
| Incidence of Premature Discontinuations in the Open-label Treatment Period | Participants were referred as premature discontinuations if they do not complete the open-label treatment period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants. | Week 48 | 
| Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period | The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7=very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period | The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 12 and Week 24 | 
| Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period | The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. | Baseline and Upto Week 24 | 
| Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the DB treatment start. | Baseline and up to Week 24 | 
| Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the OL treatment start. | Baseline and up to Week 24 | 
| Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable. | 24 weeks | 
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable. | 48 weeks | 
| Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. | 24 weeks | 
| Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. | 24 weeks | 
| Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. | 48 weeks | 
| Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable . | 24 weeks | 
| Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable . | 24 weeks | 
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 12 and Week 24 | 
| Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 12 and Week 24 | 
| Change From Baseline in Heart Rate in the Double-blind Treatment Period | The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 12 and Week 24 | 
| Change From Baseline in Heart Rate in the Open-label Treatment Period | Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 12 and Week 24 | 
| Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105). | Baseline and up to Week 24 | 
| Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105). | Baseline and up to Week 24 | 
| Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100). | Baseline and up to Week 24 | 
| Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit | Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit | Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin | Hematology parameter included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin | Hematology parameters included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count | Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count | Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and up to Week 24 | 
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable. | 24 weeks | 
| Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related. | 24 weeks | 
| Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related. | 24 weeks | 
| Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related. | 48 weeks | 
| Number of Participants With Treatment-related AEs in the Double-blind Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing. | 24 weeks | 
| Number of Participants With Treatment-related AEs in the Open-label Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing. | 24 weeks | 
| Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing. | 48 weeks | 
| Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan. | 24 weeks | 
| Number of Participants With AEs of Special Interest in the Open-label Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan. | 24 weeks | 
| Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan. | 48 weeks | 
| Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. | Baseline, Week 4, Week 12 and Week 24 | 
| Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. | Baseline, Week 4, Week 12 and Week 24 | 
| Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 4, Week 12 and Week 24 | 
| Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 4, Week 12 and Week 24 | 
| Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 4, Week 12 and Week 24 | 
| Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 4, Week 12 and Week 24 | 
| Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period | The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7= very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 12 and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, safety, sexual function, male pattern hair loss (MPHL), Androgenic alopecia (AGA), dutasteride, satisfaction with hair growth