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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by ASCEND Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
ASCEND Therapeutics
ClinicalTrials.gov Identifier:
NCT00163566
First received: September 9, 2005
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ASCEND Therapeutics:

Primary Outcome Measures:
  • Change in Body Composition

Secondary Outcome Measures:
  • Change in sexual libido, and overall function and mood
  • Normalization of serum androgen levels

Enrollment: 128
Study Start Date: October 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo gel
Placebo gel twice per day
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
Active Comparator: 0.7% DHT gel, Dose 1
0.7% DHT gel twice per day, 35 mg/day
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
Active Comparator: 0.7% DHT gel, Dose 2
0.7% DHT gel twice per day, 70 mg/day
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

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

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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: NCT00163566

Locations
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
Genesis Research Consultants
Longwood, Florida, United States, 32779
Pensacola Research Consultants
Pensacola, Florida, United States, 32503
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
Sponsors and Collaborators
ASCEND Therapeutics
Investigators
Study Director: Neta R Nelson ASCEND Therapeutics
  More Information

No publications provided

Responsible Party: ASCEND Therapeutics
ClinicalTrials.gov Identifier: NCT00163566     History of Changes
Other Study ID Numbers: 03-DHT-01
Study First Received: September 9, 2005
Last Updated: July 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ASCEND Therapeutics:
libido
depression strength
testosterone
dihydrotestosterone

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Dihydrotestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014