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Sponsors and Collaborators: |
University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) CONRAD |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00161447 |
The purpose of this research study is to help in the development of male contraception (birth control).
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 Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5) |
Enrollment: | 43 |
Study Start Date: | May 2004 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (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 (injected into muscle once)on Day 0 and at Month 3
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Drug: Testosterone Gel
Testosterone Gel (10 g daily
Drug: Depo-Medroxyprogesterone
DMPA (injected into muscle) Day 0 & month 3
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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
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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
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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.
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 J Bremner, MD, PhD | University of Washington |
Responsible Party: | University of Washington ( William J Bremner, MD, PhD ) |
Study ID Numbers: | 04-0832-D, U54 HD42454 |
Study First Received: | September 8, 2005 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00161447 |
Health Authority: | United States: Food and Drug Administration |
Male contraception testosterone acyline |
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 |