Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02014584
First received: December 12, 2013
Last updated: May 1, 2014
Last verified: April 2014
  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 24 weeks, and a subsequent Follow-up Visit after 4 weeks. 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:
  • Proportion of subjects with a change in sexual function defined as a negative change from baseline in the IIEF-EF score of >=4 units or a score of <=25 on or before Week 24 [ Time Frame: Baseline and Weeks 4, 12 and 24. ] [ 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).


Secondary Outcome Measures:
  • Proportion of subjects with a negative change from baseline in the IIEF-EF score of >=4 units or a score of <=25 on or before Weeks 4 and 12 as well as the Follow-up Visit [ Time Frame: Baseline and Weeks 4, 12 and 28. ] [ 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, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). IIEF-EF includes Questions 1 through 5 and Question 15 (maximum score of 30).

  • Change from baseline in total score of the IIEF at Weeks 4, 12, and 24 as well as the Follow-up Visit [ Time Frame: Baseline and Weeks 4, 12, 24 and 28 ] [ 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 Weeks 4, 12 and 24 as well as the Follow-up Visit [ Time Frame: Baseline and Weeks 4, 12, 24 and 28. ] [ 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 Weeks 12 and 24 [ Time Frame: Baseline and Weeks 12 and 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 Weeks 12 and 24 [ Time Frame: Baseline and Weeks 12 and 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.

  • 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 24) will be reassessed 6 months after the last dose of study medication (Extended Follow-up)


Estimated Enrollment: 700
Study Start Date: May 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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.
  • Men 18 to 50 years old, inclusively
  • AGA classified as Type III vertex, IV, or V (excluding Type IV anterior and Type V anterior) utilizing the Norwood-Hamilton classification
  • 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 Dermatology Life Quality Index 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 either agree to use effective contraception or have had a prior vasectomy. Contraception must be used 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 altered sperm after the last dose of study treatment.
  • Corrected QT interval (QTc) value <450 milliseconds (msec) or <480 msec for subjects with Bundle Branch Block, based on electrocardiogram (ECG) assessment at screening. Note: QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual overread.
  • Willing to comply with study requirements, including maintaining the same hair color throughout the study. Note: Subjects who use hair colorants/hair dyes may continue to do so.

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 <=27 on the erectile function domain (IIEF-EF) of the IIEF at screening or at the baseline visit
  • Evidence of hypogonadism defined by serum testosterone <250 nanogram (ng)/decilitre (dL) at screening
  • A clinically significant penile deformity in the opinion of the investigator
  • A communicable skin or sexually transmitted disease, or any rash or lesions on the penis or in the surrounding area
  • Serum prostate-specific antigen (PSA) >2.0 ng/milliliter (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 within the past 5 years, except basal cell or squamous cell carcinoma of the skin. Note: Subjects with suspicious ultrasound or digital rectal examination who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.
  • 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
  • Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for at least 3 months and TSH is within the reference range
  • 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; uncontrolled diabetes or peptic ulcer disease that is uncontrolled by medical management, and subjects who are known to be human immunodeficiency virus (HIV) positive (including subjects with acquired immunodeficiency syndrome [AIDS])
  • 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 GlaxoSmithKline (GSK) 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-ARI or its components or excipients or drugs chemically related to the study treatment
  • Use of dutasteride within 18 months prior to screening or use of finasteride within 12 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 during the 6 months prior to screening: 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). Note: Use of ketoconazole shampoo on the scalp is prohibited during the study, but use before screening is not a reason for exclusion. Cimetidine is prohibited during the study, but use before screening is not a reason for exclusion; Topical or systemic estrogen or progesterone; Topical prostaglandin analogs on the scalp; Tamoxifen; Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens); Drugs potentially causing hypertrichosis or telogen effluvium (e.g., valproic acid); Anabolic steroids; Lithium or phenothiazines.
  • Participation in any investigational or marketed drug or device trial within 6 months prior to screening for this study. Note: Subject must not participate in any other drug or device trials 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

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02014584     History of Changes
Other Study ID Numbers: 200209
Study First Received: December 12, 2013
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 14, 2014