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Male Hormonal Contraceptive Development-ACY-5 (ACY-5)

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ClinicalTrials.gov Identifier: NCT00161447
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 19, 2008
Information provided by:

Study Description
Brief Summary:
The purpose of this research study is to help in the development of male contraception (birth control).

Condition or disease Intervention/treatment Phase
Contraception Drug: Acyline Drug: Testosterone Gel Drug: Depo-Medroxyprogesterone Phase 1 Phase 2

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)
Study Start Date : May 2004
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
Drug: Testosterone Gel
Testosterone Gel (10 g daily
Other Name: Testim
Drug: Depo-Medroxyprogesterone
DMPA (injected into muscle) Day 0 & month 3
Other Name: DMPA
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
Drug: Acyline
Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
Drug: Testosterone Gel
Testosterone Gel (10 g daily
Other Name: Testim
Drug: Depo-Medroxyprogesterone
DMPA (injected into muscle) Day 0 & month 3
Other Name: DMPA

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels [ Time Frame: One year ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161447

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: William J Bremner, MD, PhD University of Washington
More Information

Additional Information:

Responsible Party: William J Bremner, MD, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00161447     History of Changes
Other Study ID Numbers: 04-0832-D
U54HD042454 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008

Keywords provided by University of Washington:
Male contraception

Additional relevant MeSH terms:
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Medroxyprogesterone Acetate
Contraceptive Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Male