The Effect of 5-Alpha Reductase on Testosterone in Men

• Status: Unknown status
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria

• General good health and capable of undergoing strength testing

• Normal testosterone (300-1100 ng/dL), LH, and FSH levels

Exclusion Criteria

• 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)