Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80

Hypogonadism Clinical Trial

Official title:

A Phase II, Placebo-Controlled, Double-Blind, Dose-Ranging (35mg/Day or 70 mg/Day), Randomized, Study of Cutaneous Dihydrotestosterone (DHT)-Gel (0.7% Hydroalcoholic Gel) in Older Hypogonadal Males Ages 55-80 Years: Effect on Body Composition, Libido, and Physical and Sexual Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163566
• Other study ID #: 03-DHT-01
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: September 25, 2006

Study information

• Verified date: August 2022
• Source: ASCEND Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether DHT-Gel, when applied daily to the skin, can relieve the symptoms of low testosterone in men aged 55-80. These symptoms include reduced muscle strength, increase fat mass, low libido, feeling blue or moody

Description:

Background - In the context of hypogonadism, androgen supplementation is clearly beneficial, particularly in younger males. The benefits of therapy in men with milder degrees of hypogonadism, and elderly males with testosterone deficiency, are less clear-cut. Several options are available for androgen replacement in adult men. Oral testosterone, intramuscular injections, subcutaneous implants and transdermal therapy have all been used. Each mode of delivery has advantages and drawbacks. Several alkylated derivatives of T are available for oral or sublingual use, including methyl testosterone and fluoxymesterone. However, they are not recommended for use as replacement therapy because of their associated adverse effects.

Study Design - This is a multi-center, double-blind, placebo-controlled, parallel group, randomized study of DHT-Gel versus placebo gel in male subjects ages 55-80 years inclusive with low serum testosterone and symptoms compatible with the clinical diagnosis of hypogonadism. Total enrollment for this study will be approximately 120 subjects (40 subjects for each treatment group). Subjects will be treated with 35 mg/day DHT, 70 mg/day DHT, or placebo gel for 6 months. All subjects will apply the gel once daily. Up to 9 months of study participation, including up to 2 months of screening and a 1-month follow-up period, will be required by the protocol.

The primary efficacy endpoint in this study is change in body composition as determined by DEXA scan. Secondary endpoints in this study include change in sexual libido, and overall function and mood, and normalization of serum androgen levels. A subset of sites will perform strength assessments, which will include handgrip dynamometry, and upper and lower body strength tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 25, 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men aged 55-80 Serum Testosterone < 275 Symptoms of Hypogonadism as determined by AMS scale In good overall health

Exclusion Criteria:

• Abnormal Prostate Exam for age Prostate or Breast Cancer Significant illness Weight >300lbs Generalized skin disease Unstable sleep apnea

Related Conditions & MeSH terms

• Hypogonadism
• Low Testosterone

Intervention

Drug:
• Dihydrotestosterone (0.7%) in hydroalcoholic gel
transdermal gel, 0.7% DHT, 0.35 mg/day or 0.70 mg/day total daily dose (or placebo gel), applied twice per day

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Bethesda Health Research	Bethesda	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	North Indiana Research	Fort Wayne	Indiana
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	VA Medical Center	Houston	Texas
United States	Genesis Research Consultants	Longwood	Florida
United States	University of Louisville	Louisville	Kentucky
United States	Pensacola Research Consultants	Pensacola	Florida
United States	Radiant Research - Phoenix	Phoenix	Arizona
United States	Oregon Health Sciences Center	Portland	Oregon
United States	McGuire VA Medical Center	Richmond	Virginia
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Radiant Research - San Antonio	San Antonio	Texas
United States	VA Puget Sound Health Care	Seattle	Washington
United States	Harbor UCLA Medical Reserach and Education Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
ASCEND Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Composition
Secondary	Change in sexual libido, and overall function and mood
Secondary	Normalization of serum androgen levels