Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT02014584
First received: December 12, 2013
Last updated: April 20, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Alopecia
Drug: Dutasteride
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Study of Sexual Function in Men Taking Dutasteride for the Treatment of Androgenetic Alopecia

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of adverse events related to sexual dysfunction [ Time Frame: Up to 6 months after the last dose of study medication ] [ Designated as safety issue: No ]
    Any adverse events related to sexual dysfunction will be carefully monitored during the study, and any such events ongoing at the end of treatment (Week 48) will be reassessed up to 6 months after the last dose of study medication (Extended Follow-up)


Secondary Outcome Measures:
  • Change from baseline in total score of the IIEF at double-blind weeks 4, 12, 24, open-label day 1, open-label weeks 4, 12, 24, follow-up visit. [ Time Frame: Baseline and double-blind Weeks 4, 12, 24, open-label day 1, open-label weeks 4, 12, 24, follow-up visit, and (if needed) targeted follow-up visit. ] [ Designated as safety issue: No ]
    IIEF questionnaire is used to assess erectile function. It is a 15-item questionnaire with individual items assigned to five separate domains of sexual function: Erectile function (Questions 1 through 5 and 15), Orgasmic function (Questions 9 and 10), Sexual desire (Questions 11 and 12), Intercourse satisfaction (Questions 6 through 8), and Overall satisfaction (Questions 13 and 14).

  • Change from baseline in the individual domain scores: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction, of the IIEF at double-blind and open-label weeks 4, 12, 24, follow-up visit. [ Time Frame: Baseline and double-blind Weeks 4, 12, 24, open-label day 1, open-label weeks 4, 12, 24, follow-up visit, and (if needed) targeted follow-up visit. ] [ Designated as safety issue: No ]
    IIEF questionnaire is used to assess erectile function. It is a 15-item questionnaire with individual items assigned to five separate domains of sexual function: Erectile function (Questions 1 through 5 and 15), Orgasmic function (Questions 9 and 10), Sexual desire (Questions 11 and 12), Intercourse satisfaction (Questions 6 through 8), and Overall satisfaction (Questions 13 and 14).

  • Change from baseline in subject satisfaction with hair growth as assessed by the total score of the Hair Growth Satisfaction Scale (HGSS) at double-blind Weeks 12, 24, open-label day 1, open-label week 24. [ Time Frame: Baseline and double-blind Weeks 12, 24, open-label day 1, open-label week 24. ] [ Designated as safety issue: No ]
    The HGSS will assess subject satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from very dissatisfied to very satisfied.

  • Change from baseline in the total score of the Dermatology Life Quality Index (DLQI) at double-blind Weeks 12, 24, open-label day 1, open-label week 24. [ Time Frame: Baseline and double-blind Weeks 12, 24, open-label day 1, open-label week 24. ] [ Designated as safety issue: No ]
    The DLQI is a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the subjects' quality of life. Each item is scored on a 4-point scale.

  • Proportion of subjects with a change in sexual function defined as a negative change from baseline in the IIEF-EF score of >=4 units on or before Week 24 or 48. [ Time Frame: Baseline and week 24 or 48. ] [ Designated as safety issue: No ]
    International Index of Erectile Function (IIEF) questionnaire is used to assess erectile function. It is a 15-item questionnaire with individual items assigned to five separate domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). Erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30).

  • Occurrence of adverse events including adverse events of special interest. [ Time Frame: At all treatment visits and at the follow-up visit (4-6 weeks after last treatment). ] [ Designated as safety issue: No ]
    Incidence of adverse events.


Estimated Enrollment: 120
Study Start Date: July 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dutasteride Arm
Subjects will receive dutasteride 0.5 milligrams (mg) administered orally once daily for 24 Weeks
Drug: Dutasteride
Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally.
Placebo Comparator: Placebo Arm
Subjects will receive placebo administered orally once daily for 24 Weeks
Drug: Placebo
Dutasteride matching placebo will be supplied as capsules to be administered orally.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014584

Locations
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7580206
Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Korea, Republic of
GSK Investigational Site
Chungcheongnam-do, Korea, Republic of
GSK Investigational Site
Daejeon, Korea, Republic of, 301-721
GSK Investigational Site
Gwangju, Korea, Republic of, 501-757
GSK Investigational Site
Gyeonggi-do, Korea, Republic of, 463-707
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
GSK Investigational Site
Kangwon-Do, Korea, Republic of, 220-701
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 143-729
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 156-755
GSK Investigational Site
Seoul, Korea, Republic of, 134-090
Singapore
GSK Investigational Site
Singapore, Singapore, 169608
Taiwan
GSK Investigational Site
Taipei, Taiwan, 106
GSK Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT02014584     History of Changes
Other Study ID Numbers: 200209
Study First Received: December 12, 2013
Last Updated: April 20, 2015
Health Authority: Korea: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
satisfaction with hair growth
sexual function
dutasteride
male pattern hair loss (MPHL)
safety
Androgenic alopecia (AGA)
quality of life

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on April 26, 2015