Male Hormonal Contraceptive Development-ACY-5

University of Washington

Status and phase: Completed; Phase 2; Phase 1

Conditions: Contraception

Treatments: Drug: Testosterone Gel; Drug: Depo-Medroxyprogesterone; Drug: Acyline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00161447

04-0832-D

U54HD042454 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: Testosterone Gel

Drug: Depo-Medroxyprogesterone

2

Active Comparator group

Description:

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

Treatment:

Drug: Acyline

Drug: Testosterone Gel

Drug: Depo-Medroxyprogesterone