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

This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. Participation is voluntary.

The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.

Study Type: Interventional

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

Study Primary Completion Date: July 2005

The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all individuals enrolled achieve azoospermia (zero sperm). However, early data demonstrated that some individuals have persistent sperm in their semen despite treatment. We hope to be able to determine whether differences in intratesticular hormone levels account for persistent sperm production in men who do not reach counts of zero as compared to those who do in the male contraceptive study. This study will measure testosterone levels in the testes of men who are participating in male contraceptive studies. Testosterone will be measured in a small amount of testicular fluid at the end of the study treatment phase after sperm counts have been reduced to zero or very low levels.

Intervention(s) in this Clinical Trial

• Drug: Acyline
  • Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks
• Drug: Testosterone Gel
  • Testosterone (T) gel 10 g daily for 6 months
• Drug: Depo-Medroxyprogesterone
  • 300 mg IM every 3 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Testosterone (T) gel for 6 months + DMPA (Depo-Medroxyprogesterone) (injected into muscle Day 0 & at Month 3)
• Active Comparator: 2
  • T gel for 6 months + DMPA (Day 0 & Month 3) + Acyline 300 mcg/kg twice monthly for 12 weeks

Primary Measures

• Intratesticular hormone levels
  • Time Frame: One year
    Safety Issue?: No

Secondary Measures

• sperm count levels
  • Time Frame: One year
    Safety Issue?: No

Inclusion Criteria:

• Male between 18-55
• In good health
• With normal sperm counts and willing to use an acceptable form of contraception during the study

Exclusion Criteria:

• Male in poor health
• Significant chronic or acute medical illness
• Skin conditions that might interfere with or be exacerbated by testosterone gel
• No history of alcohol, illicit drug or anabolic steroid abuse
• Abnormal reproductive function
• Participation in a long-term male contraceptive study within three months of screening

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 Bremner, MD Principal Investigator University of Washington  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00156650

Study ID Number: 04-0832-D-substudy

ClinicalTrials.gov Identifier: NCT00156650

Health Authority: United States: Food and Drug Administration

University of Washington