Male Hormonal Contraceptive Development-ACY-5

Phase 1

Completed

• Conditions: Contraception
• Interventions: Drug: Testosterone Gel; Drug: Acyline; Drug: Depo-Medroxyprogesterone

• Registration Number: NCT00161447
• Lead Sponsor: University of Washington

Brief Summary

The purpose of this research study is to help in the development of male contraception (birth control).

Detailed Description

The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone (T) and the progestin depo-medroxyprogesterone acetate (DMPA).

We will be administering combinations of three drugs: Testosterone (T) by gel, Depot Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The T/DMPA/Acyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis.

In prior studies with testosterone and DMPA these drug, which are hormones, have been found to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to improve this to 100% of men by adding another drug, Acyline.

Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of spermatogenesis to zero (azoospermia) by the end of the treatment phase.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-18
• Last Update Posted: 2008-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

• Males between 18-55
• In good general health
• With normal sperm counts
• Willing to use an acceptable form of contraception

Exclusion Criteria

• Men in poor health
• Significant chronic or acute medical illness
• Skin conditions that might interfere with or be exacerbated by testosterone gel
• Known history of alcohol, illicit drug or anabolic steroid abuse
• Abnormal reproductive function
• Participation in a long-term male contraceptive study within past three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Depo-Medroxyprogesterone	Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 \& at month 3) + Acyline (SQ) every two weeks for the first 12 weeks
1	Testosterone Gel	Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
1	Depo-Medroxyprogesterone	Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
2	Testosterone Gel	Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 \& at month 3) + Acyline (SQ) every two weeks for the first 12 weeks
2	Acyline	Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 \& at month 3) + Acyline (SQ) every two weeks for the first 12 weeks

Primary Outcome Measures

Name	Time	Method
The primary biological end points in this trial will be suppression of spermatogenesis and gonadotropins while monitoring for any adverse changes in lipid metabolism, sexual side effects or in general health	One year

Secondary Outcome Measures

Name	Time	Method
Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels	One year

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States