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

NCT00163566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-08-15

No results posted yet for this study

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

Conditions

  • Hypogonadism
  • Late Onset Hypogonadism
  • Low Testosterone

Interventions

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

Sponsors & Collaborators

  • ASCEND Therapeutics

    lead INDUSTRY

Principal Investigators

  • Neta R Nelson · ASCEND Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-09-30
Completion
2006-09-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00163566 on ClinicalTrials.gov