The Effect of 5-Alpha Reductase on Testosterone in Men
The Role of 5-Alpha Reductase in Mediating Testosterone Actions
1 other identifier
interventional
184
1 country
1
Brief Summary
The enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone to dihydrotestosterone (DHT). Testosterone affects lean body tissue, muscle size, muscle strength, and sexual function in men. This study will evaluate how 5-alpha reductase influences the effects of testosterone in young healthy men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 7, 2003
CompletedFirst Posted
Study publicly available on registry
October 10, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedNovember 7, 2005
October 1, 2003
October 7, 2003
November 4, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- General good health and capable of undergoing strength testing
- Normal testosterone (300-1100 ng/dL), LH, and FSH levels
You may not qualify if:
- Currently participating in competitive sports
- Mental state that would preclude complete understanding of the protocol and compliance
- Disorder known to cause or be associated with hypogonadism (e.g., pituitary tumors, hyperprolactinemia, HIV infection, or Klinefelter's Syndrome)
- More than 20% over ideal body weight
- Disabilities that would prevent participation in strength testing (e.g., amputation of limbs, blindness, severe arthritis, angina, or neurologic disorders such as Parkinson's disease, stroke, or myopathy)
- Uncontrolled hypertension, diabetes, congestive heart failure, or chronic obstructive lung disease
- Alcohol or drug dependence in the 6 months prior to study entry
- Disorders that might be exacerbated by androgen treatment (e.g., benign prostatic hyperplasia or prostate cancer, erythrocytosis \[hematocrit \> 51% at baseline\], or sleep apnea assessed by Berlin's questionnaire)
- Serum PSA levels \> 4 microg/L
- AST, ALT, or alkaline phosphatase elevation greater than three times the upper limit of normal
- Creatinine greater than 2 mg/dL
- Medications that might affect muscle or bone metabolism (e.g., glucocorticoid, rhGH, androgenic steroids, oral androgen precursors such as androstenedione or DHEA) or androgen metabolism, action, or clearance (e.g., dilantin, phenobarbitol, aldactone, flutamide, finasteride)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charles R. Drew University
Los Angeles, California, 90059, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shalender Bhasin, MD
Charles R. Drew University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 7, 2003
First Posted
October 10, 2003
Study Start
August 1, 2003
Study Completion
June 1, 2005
Last Updated
November 7, 2005
Record last verified: 2003-10