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Sponsored by: |
ASCEND Therapeutics |
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Information provided by: | ASCEND Therapeutics |
ClinicalTrials.gov Identifier: | NCT00163566 |
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
Condition | Intervention | Phase |
---|---|---|
Hypogonadism, Late Onset Hypogonadism, Low Testosterone |
Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | October 2004 |
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.
Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Radiant Research - Phoenix | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
Harbor UCLA Medical Reserach and Education Institute | |
Torrance, California, United States, 90502 | |
United States, Florida | |
Malcom Randall VA Medical Center | |
Gainesville, Florida, United States, 32608 | |
Pensacola Research Consultants | |
Pensacola, Florida, United States, 32503 | |
Genesis Research Consultants | |
Longwood, Florida, United States, 32779 | |
United States, Indiana | |
North Indiana Research | |
Fort Wayne, Indiana, United States, 46825 | |
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
Bethesda Health Research | |
Bethesda, Maryland, United States, 20817 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Oregon | |
Oregon Health Sciences Center | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
VA Medical Center | |
Houston, Texas, United States, 77030 | |
Radiant Research - San Antonio | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
University of Utah School of Medicine | |
Salt Lake City, Utah, United States, 84108 | |
United States, Virginia | |
McGuire VA Medical Center | |
Richmond, Virginia, United States, 23249 | |
United States, Washington | |
VA Puget Sound Health Care | |
Seattle, Washington, United States, 98108 |
Study Director: | Neta R Nelson | ASCEND Therapeutics |
Study ID Numbers: | 03-DHT-01 |
Study First Received: | September 9, 2005 |
Last Updated: | February 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00163566 History of Changes |
Health Authority: | United States: Food and Drug Administration |
libido depression strength testosterone dihydrotestosterone |
Depression Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Depressive Disorder |
Hormones Testosterone 17 beta-cypionate Testosterone Hypogonadism Dihydrotestosterone Endocrinopathy Androgens |
Testosterone Hypogonadism Gonadal Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Endocrine System Diseases Dihydrotestosterone Hormones Pharmacologic Actions Androgens |