Status:
COMPLETED
Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80
Lead Sponsor:
ASCEND Therapeutics
Conditions:
Hypogonadism
Late Onset Hypogonadism
Eligibility:
MALE
55-80 years
Phase:
PHASE2
Brief 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...
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 elde...
Eligibility Criteria
Inclusion
- Men aged 55-80 Serum Testosterone \< 275 Symptoms of Hypogonadism as determined by AMS scale In good overall health
Exclusion
- Abnormal Prostate Exam for age Prostate or Breast Cancer Significant illness Weight \>300lbs Generalized skin disease Unstable sleep apnea
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2006
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00163566
Start Date
October 1 2004
End Date
September 25 2006
Last Update
August 15 2022
Active Locations (16)
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1
Radiant Research - Phoenix
Phoenix, Arizona, United States, 85013
2
Harbor UCLA Medical Reserach and Education Institute
Torrance, California, United States, 90502
3
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608
4
Genesis Research Consultants
Longwood, Florida, United States, 32779