Trial | NCT00161447  Report issue

Title

Male Hormonal Contraceptive Development-ACY-5
Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    43
The purpose of this research study is to help in the development of male contraception (birth control).
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 Started
May 31
2004
Primary Completion
Apr 30
2006
Study Completion
Apr 30
2006
Last Update
Sep 19
2008
Estimate

Drug Acyline

Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks

Drug Testosterone Gel

Testosterone Gel (10 g daily

  • Other names: Testim

Drug Depo-Medroxyprogesterone

DMPA (injected into muscle) Day 0 & month 3

  • Other names: DMPA

1 Active Comparator

Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3

2 Active Comparator

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

Criteria 

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
No Results Posted