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Oral Androgens in Man-4: (Short Title: Oral T-4)

NCT00399165 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-09-22

No results posted yet for this study

Summary

The protocol was designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval

Conditions

  • Contraception

Interventions

DRUG

Testosterone Enanthate

Oral Testosterone 400 mg orally for 28 days

DRUG

Testosterone Enanthate

Oral Testosterone 800 mg orally for 28 days

DRUG

Dutasteride

dutasteride 0.5 mg orally, once daily for 28 days

OTHER

placebo sesame oil

placebo sesame oil

DRUG

Dutasteride

24.5 mg po once (Day 0)

Sponsors & Collaborators

Principal Investigators

  • John K Amory, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399165 on ClinicalTrials.gov