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Sponsors and Collaborators: |
University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00156650 |
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.
Condition | Intervention | Phase |
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Contraception |
Drug: Acyline Drug: Testosterone Gel Drug: Depo-Medroxyprogesterone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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) |
Enrollment: | 23 |
Study Start Date: | December 2004 |
Study Completion Date: | July 2005 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Testosterone (T) gel for 6 months + DMPA (Depo-Medroxyprogesterone) (injected into muscle Day 0 & at Month 3)
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Drug: Testosterone Gel
Testosterone (T) gel 10 g daily for 6 months
Drug: Depo-Medroxyprogesterone
300 mg IM every 3 months
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2: Active Comparator
T gel for 6 months + DMPA (Day 0 & Month 3) + Acyline 300 mcg/kg twice monthly for 12 weeks
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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
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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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | William Bremner, MD | University of Washington |
Responsible Party: | University of Washington ( William J Bremner, MD, PhD ) |
Study ID Numbers: | 04-0832-D-substudy, U54 HD42454 |
Study First Received: | September 8, 2005 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00156650 |
Health Authority: | United States: Food and Drug Administration |
Male contraception Testosterone |
Testosterone Medroxyprogesterone 17-Acetate Medroxyprogesterone Methyltestosterone Testosterone 17 beta-cypionate |
Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents |
Contraceptive Agents, Male Hormones Pharmacologic Actions Anabolic Agents Therapeutic Uses Contraceptives, Oral, Synthetic Androgens |