Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80
NCT ID: NCT00163566
Last Updated: 2022-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2004-10-31
2006-09-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo gel
Placebo gel twice per day
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
0.7% DHT gel, Dose 1
0.7% DHT gel twice per day, 35 mg/day
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
0.7% DHT gel, Dose 2
0.7% DHT gel twice per day, 70 mg/day
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
55 Years
80 Years
MALE
No
Sponsors
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ASCEND Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Neta R Nelson
Role: STUDY_DIRECTOR
ASCEND Therapeutics
Locations
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Radiant Research - Phoenix
Phoenix, Arizona, United States
Harbor UCLA Medical Reserach and Education Institute
Torrance, California, United States
Malcom Randall VA Medical Center
Gainesville, Florida, United States
Genesis Research Consultants
Longwood, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States
North Indiana Research
Fort Wayne, Indiana, United States
University of Louisville
Louisville, Kentucky, 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
Oregon Health Sciences Center
Portland, Oregon, United States
VA Medical Center
Houston, Texas, United States
Radiant Research - San Antonio
San Antonio, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
McGuire VA Medical Center
Richmond, Virginia, United States
VA Puget Sound Health Care
Seattle, Washington, United States
Countries
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Other Identifiers
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03-DHT-01
Identifier Type: -
Identifier Source: org_study_id
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