NCT02014584CompletedPhase 3
A Prospective Study of Sexual Function in Men Taking Dutasteride for the Treatment of Androgenetic Alopecia
Stiefel, a GSK Company1 site in 1 country117 target enrollmentStarted: July 2, 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dutasteride Arm
Experimental
Subjects will receive dutasteride 0.5 milligrams (mg) administered orally once daily for 24 Weeks
Intervention: Dutasteride (Drug)
Placebo Arm
Placebo Comparator
Subjects will receive placebo administered orally once daily for 24 Weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period
Time Frame: 24 weeks
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.
Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period
Time Frame: 24 weeks
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.
Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods
Time Frame: 48 weeks
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.
Secondary Outcomes
- Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period(24 weeks)
- Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period(24 weeks)
- Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods(48 weeks)
- Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period(24 weeks)
- Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period(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(48 weeks)
- Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period(24 weeks)
- Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period(24 weeks)
- Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods(48 weeks)
- Number of Participants With Treatment-related AEs in the Double-blind Treatment Period(24 weeks)
- Number of Participants With Treatment-related AEs in the Open-label Treatment Period(24 weeks)
- Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods(48 weeks)
- Number of Participants With AEs of Special Interest in the Double-blind Treatment Period(24 weeks)
- Number of Participants With AEs of Special Interest in the Open-label Treatment Period(24 weeks)
- Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period(24 weeks)
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period(Baseline, Week 12 and Week 24)
- Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period(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(Baseline and up to Week 24)
- Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods(48 weeks)
- Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period(24 weeks)
- Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin(Baseline and up to Week 24)
- Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin(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(Baseline and up to Week 24)
- Change From Baseline in Heart Rate in the Double-blind Treatment Period(Baseline, Week 12 and Week 24)
- Change From Baseline in Heart Rate in the Open-label Treatment Period(Baseline, Week 12 and Week 24)
- Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period(Baseline and up to Week 24)
- Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit(Baseline and up to Week 24)
- Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit(Baseline and up to Week 24)
- Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period(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)(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.(Baseline and up to Week 24)
- Incidence of Premature Discontinuations in the Double-blind Treatment Period(Week 24)
- Incidence of Premature Discontinuations in the Open-label Treatment Period(Week 48)
- Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period(Baseline and up to Week 24)
- Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period(Baseline and up to Week 24)
- Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period(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(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(Baseline and up to Week 24)
- Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein(Baseline and up to Week 24)
- Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period(Baseline and up to Week 24)
- Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period(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(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.(Baseline and up to Week 24)
- 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(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(Baseline, Week 4, Week 12 and Week 24)
- Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period(Baseline, Week 4, Week 12 and Week 24)
- Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period(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(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(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(Baseline, Week 12 and Week 24)
- Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period(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(Baseline, Week 12 and Week 24)
- Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period(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(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(Baseline and up to Week 24)
Investigators
Study Sites (1)
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