The Effects of Testosterone on Prostate Tissue (ACYP-1)

NCT00161486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2008-09-19

No results posted yet for this study

Summary

The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

Conditions

  • Hypogonadism
  • Contraception

Interventions

DRUG

Testosterone gel

Testosterone gel 100 mg daily for 4 weeks

DRUG

Acyline

Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks

DRUG

Placebo acyline

Placebo acyline injections every two weeks (2 doses)

DRUG

Placebo Testosterone gel

placebo testosterone gel daily for 4 weeks

Sponsors & Collaborators

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

    collaborator NIH
  • University of Washington

    lead OTHER

Principal Investigators

  • William J Bremner, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2004-11-30
Completion
2004-11-30

Countries

  • United States

Study Locations

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Entities

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 NCT00161486 on ClinicalTrials.gov