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

August 11, 2022 updated by: ASCEND Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Radiant Research - Phoenix
    • California
      • Torrance, California, United States, 90502
        • Harbor UCLA Medical Reserach and Education Institute
    • Florida
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VA Medical Center
      • Longwood, Florida, United States, 32779
        • Genesis Research Consultants
      • Pensacola, Florida, United States, 32503
        • Pensacola Research Consultants
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • North Indiana Research
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Bethesda, Maryland, United States, 20817
        • Bethesda Health Research
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences Center
    • Texas
      • Houston, Texas, United States, 77030
        • VA Medical Center
      • San Antonio, Texas, United States, 78229
        • Radiant Research - San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah School of Medicine
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in Body Composition

Secondary Outcome Measures

Outcome Measure
Change in sexual libido, and overall function and mood
Normalization of serum androgen levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASCEND Therapeutics

Investigators

  • Study Director: Neta R Nelson, ASCEND Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 25, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-DHT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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