Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

NCT02014584 | Completed Phase 3 Results

• 1 other identifier: 200209
• Study Type: interventional
• Target: 117
• Locations: 5 countries
• Sites: 18

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.

Conditions

Alopecia

Keywords

quality of life; safety; sexual function; male pattern hair loss (MPHL); Androgenic alopecia (AGA); dutasteride; satisfaction with hair growth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (55)

• 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

Study Arms (2)

Dutasteride Arm

EXPERIMENTAL

Subjects will receive dutasteride 0.5 milligrams (mg) administered orally once daily for 24 Weeks

Drug: Dutasteride

Placebo Arm

PLACEBO COMPARATOR

Subjects will receive placebo administered orally once daily for 24 Weeks

Drug: Placebo

Interventions

Dutasteride DRUG

Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally.

Dutasteride Arm

Placebo DRUG

Dutasteride matching placebo will be supplied as capsules to be administered orally.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (18)

GSK Investigational Site

Santiago, Región Metro de Santiago, 7580206, Chile

Location

GSK Investigational Site

Pokfulam, Hong Kong

Location

GSK Investigational Site

Shatin, Hong Kong

Location

GSK Investigational Site

Singapore, 169608, Singapore

Location

GSK Investigational Site

Chungcheongnam-do, South Korea

Location

GSK Investigational Site

Daejeon, 301-721, South Korea

Location

GSK Investigational Site

Gwangju, 501-757, South Korea

Location

GSK Investigational Site

Gyeonggi-do, 463-707, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Jeonju-si, Jeollabuk-do, 561-712, South Korea

Location

GSK Investigational Site

Kangwon-Do, 220-701, South Korea

Location

GSK Investigational Site

Pusan, 602-739, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 134-090, South Korea

Location

GSK Investigational Site

Seoul, 143-729, South Korea

Location

GSK Investigational Site

Seoul, 156-755, South Korea

Location

GSK Investigational Site

Taipei, 106, Taiwan

Location

GSK Investigational Site

Taipei, Taiwan

Location

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Alopecia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: July 2, 2014
• Primary Completion: March 19, 2016
• Study Completion: March 19, 2016
• Last Updated: October 11, 2018
• Results First Posted: March 8, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

SG (1); HK (2); CL (1); KR (12); TW (2)