search
Back to results

The Effect of 5-Alpha Reductase on Testosterone in Men

Primary Purpose

Sex Disorders

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
testosterone enanthate
duastride
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sex Disorders focused on measuring Testosterone, 5-alpha Reductase, Muscle Strength, Libido, Sexual Function, Muscle Mass, Testosterone 5-alpha-Reductase

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Charles R. Drew UniversityRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 7, 2003
Last Updated
November 4, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00070733
Brief Title
The Effect of 5-Alpha Reductase on Testosterone in Men
Official Title
The Role of 5-Alpha Reductase in Mediating Testosterone Actions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

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.
Detailed Description
Testosterone, the predominant circulating androgen in men, serves as the active hormone in some target tissues; however, testosterone effects in other target organs require its conversion to two active metabolites, estradiol 17-beta and DHT. The role of 5-alpha reductase in mediating testosterone's effects on muscle and sexual function remains unclear. This study will determine whether 5-alpha reduction of testosterone to DHT is necessary for mediating effects on fat-free mass, muscle size, muscle strength, and leg power in men. The study will also evaluate the necessity of 5-alpha reductase for maintenance of androgen effects on sexual function (sexual desire, overall sexual activity, nocturnal penile tumescence [NPT], response to visual erotic stimulus, and penile rigidity) in men. Participants in this study will be treated with a drug to suppress endogenous testosterone production. Participants will then be randomly assigned to receive either testosterone and placebo or testosterone and the 5-alpha reductase inhibitor dutasteride. Testosterone will be administered weekly; dutasteride and placebo will both be administered daily. Diet and exercise will be standardized across both groups. Participants will be assessed at study entry and Week 20. Assessments will include measurements such as a DEXA scan, MRI scan, and muscle performance and sexual function tests. Participants will also have blood tests for safety monitoring; blood tests will include measures of hematocrit, liver enzymes (AST and ALT), prostate specific antigen (PSA), and cholesterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sex Disorders
Keywords
Testosterone, 5-alpha Reductase, Muscle Strength, Libido, Sexual Function, Muscle Mass, Testosterone 5-alpha-Reductase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
184 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
testosterone enanthate
Intervention Type
Drug
Intervention Name(s)
duastride

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD
Organizational Affiliation
Charles R. Drew University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD
Phone
323-563-9353

12. IPD Sharing Statement

Learn more about this trial

The Effect of 5-Alpha Reductase on Testosterone in Men

We'll reach out to this number within 24 hrs