Clinical trial NCT00163566: Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Late Onset Hypogonadism
Low Testosterone
Keywords: libido
depression strength
testosterone
dihydrotestosterone
Lead sponsor: ASCEND Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 128
Sex: MALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Composition
Secondary outcomes:
measure: Change in sexual libido, and overall function and mood
measure: Normalization of serum androgen levels
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Radiant Research - Phoenix
state: Arizona
city: Torrance
country: United States
facility: Harbor UCLA Medical Reserach and Education Institute
state: California
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
city: Longwood
country: United States
facility: Genesis Research Consultants
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants
state: Florida
city: Fort Wayne
country: United States
facility: North Indiana Research
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bethesda
country: United States
facility: Bethesda Health Research
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences Center
state: Oregon
city: Houston
country: United States
facility: VA Medical Center
state: Texas
city: San Antonio
country: United States
facility: Radiant Research - San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care
state: Washington
Study officials:
affiliation: ASCEND Therapeutics
name: Neta R Nelson
role: STUDY_DIRECTOR
References: