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

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

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Acyline
  • Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
• Drug: Testosterone Gel
  • Testosterone Gel (10 g daily
• Drug: Depo-Medroxyprogesterone
  • DMPA (injected into muscle) Day 0 & month 3

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
• Active Comparator: 2
  • 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 Measures

• 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
  • Time Frame: One year
    Safety Issue?: Yes

Secondary Measures

• Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels
  • Time Frame: One year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Washington

Overall Clinical Trial Officials and Contacts

William J Bremner, MD, PhD Principal Investigator University of Washington  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00161447

Study ID Number: 04-0832-D

ClinicalTrials.gov Identifier: NCT00161447

Health Authority: United States: Food and Drug Administration

http://depts.washington.edu/popctr