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28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men

NCT00398580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-05-30

No results posted yet for this study

Summary

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.

Conditions

  • Hypogonadism
  • Hypogonadism, Male

Interventions

DRUG

Nanomilled testosterone

DRUG

Nanomilled dutasteride

DRUG

commercially available dutasteride

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials, M.D., Ph.D., FACP · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-10-31
Completion
2007-10-31

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 NCT00398580 on ClinicalTrials.gov