The Role of 5-alpha Reductase in Mediating Testosterone Actions

NCT00493987 | Completed Phase 4

• 1 other identifier: R01HD043348
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

In normal men, the male hormone testosterone affects a number of things in the body including muscle function and sexual function. An enzyme in the body called 5-alpha reductase converts testosterone into another form called dihydrotestosterone (DHT) which has slightly different effects. The purpose of this study is to find out how different amounts of the two different forms of testosterone affect muscle function and sexual function in healthy young men like you. This will be done by giving the men participating in the study different combinations of hormone-related medication for 20 weeks and making measurements before, during and after the medications to look for changes in lean body tissue, muscle size, muscle strength and leg power, as well as sexual function and sexual activity in all participants.

Conditions

Healthy

Keywords

Testosterone; Androgens; Dihydrotestosterone; 5-alpha reductase; Body Composition; Muscle; Sexual function; Men; Healthy Men

Outcome Measures

Primary Outcomes (1)

• Change from baseline in fat-free mass, measured by DEXA scanning

  20 weeks

Secondary Outcomes (12)

• Body composition by Deuterium dilution method

  20 weeks

• Maximal voluntary strength in the leg press and chest press exercises.

  20 weeks

• Upper and lower extremity muscle power

  20 weeks

• Muscle volume by MRI scan

  20 weeks

• Prostate volume by MRI Scan

  20 weeks

Study Arms (2)

Testosterone enanthate

ACTIVE COMPARATOR

Drug: Testosterone Enanthate

Duatesteride

PLACEBO COMPARATOR

Duatesteride

Drug: Dutasteride

Interventions

Testosterone Enanthate DRUG

testosterone ester

Testosterone enanthate

Dutasteride DRUG

5 alpha-reductase inhibitor

Duatesteride

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males between 18 and 50 years of age.
• Ambulatory, physically active, but not in competitive sports.
• Eugonadal: Normal Serum Testosterone (300-1100 nmol/L).
• Normal LH
• Normal FSH
• Able and willing to comply with the trial protocol.

You may not qualify if:

• Known to have a primary or secondary hypogonadism? (e.g. pituitary disease, HIV infection, Klinefelter's Syndrome)
• BMI \> 35
• Disability that precludes participation in exercise testing
• Alcohol or illicit drug use in the preceding 6 months that would interfere with participation and compliance with the protocol
• Known disorder that would be exacerbated by androgen treatment e.g. benign prostate hyperplasia, prostate Ca, erythrocytosis, sleep apnea)
• Any abnormalities in the following laboratory tests PSA \> 4 ng/ml AST, ALT or Alkaline Phosphatase \> 3x ULN? Creatinine level \> 2 mg/dL Hematocrit \> 51%
• Osteoporosis by DEXA BMD T-Score \< -2.5
• Use of medications that affect muscle or bone metabolism within the previous 3 months ?(e.g. glucocorticoids, growth hormone, androgenic steroids, oral androgen precursors -i.e. androstenedione or DHEA)
• Use of medications that affect androgen metabolism, action or clearance within the previous 3 months? (e.g. dilantin, phenobarbital, aldactone, flutamide, finasteride and Ketoconazole)
• Use of ketoconazole or other potent CYP3A4 inhibitors that may affect clearance of dutasteride
• Use investigational medication as part of a research study in the last 3 months?

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• Tapper J, Arver S, Pencina KM, Martling A, Blomqvist L, Buchli C, Li Z, Gagliano-Juca T, Travison TG, Huang G, Storer TW, Bhasin S, Basaria S. Muscles of the trunk and pelvis are responsive to testosterone administration: data from testosterone dose-response study in young healthy men. Andrology. 2018 Jan;6(1):64-73. doi: 10.1111/andr.12454.

  PMID: 29280355 DERIVED

• Bhasin S, Travison TG, Storer TW, Lakshman K, Kaushik M, Mazer NA, Ngyuen AH, Davda MN, Jara H, Aakil A, Anderson S, Knapp PE, Hanka S, Mohammed N, Daou P, Miciek R, Ulloor J, Zhang A, Brooks B, Orwoll K, Hede-Brierley L, Eder R, Elmi A, Bhasin G, Collins L, Singh R, Basaria S. Effect of testosterone supplementation with and without a dual 5alpha-reductase inhibitor on fat-free mass in men with suppressed testosterone production: a randomized controlled trial. JAMA. 2012 Mar 7;307(9):931-9. doi: 10.1001/jama.2012.227.

  PMID: 22396515 DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

testosterone enanthate; Dutasteride

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shalender Bhasin, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: November 1, 2002
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: May 13, 2010

Record last verified: 2009-01

Locations

US (1)