The Effects of Testosterone on Prostate Tissue (ACYP-1)
NCT00161486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2008-09-19
Summary
The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.
Conditions
- Hypogonadism
- Contraception
Interventions
- DRUG
-
Testosterone gel
Testosterone gel 100 mg daily for 4 weeks
- DRUG
-
Acyline
Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks
- DRUG
-
Placebo acyline
Placebo acyline injections every two weeks (2 doses)
- DRUG
-
Placebo Testosterone gel
placebo testosterone gel daily for 4 weeks
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH - lead OTHER
Principal Investigators
-
William J Bremner, MD · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2004-07-31
- Primary Completion
- 2004-11-30
- Completion
- 2004-11-30
Countries
- United States
Study Locations
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