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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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
Actual Primary Completion Date :	April 2006
Actual Study Completion Date :	April 2006

Arms and Interventions

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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

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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)

CONRAD

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

http://depts.washington.edu/popctr 

Publications of Results:

Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. Epub 2006 Aug 29.

Amory JK, Page ST, Anawalt BD, Matsumoto AM, Bremner WJ. Acceptability of a combination testosterone gel and depomedroxyprogesterone acetate male contraceptive regimen. Contraception. 2007 Mar;75(3):218-23. Epub 2007 Jan 16.

Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. Epub 2007 May 9.

Other Publications:

Meriggiola MC, Bremner WJ, Costantino A, Di Cintio G, Flamigni C. Low dose of cyproterone acetate and testosterone enanthate for contraception in men. Hum Reprod. 1998 May;13(5):1225-9.

Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.

Kamischke A, Venherm S, Plöger D, von Eckardstein S, Nieschlag E. Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab. 2001 Jan;86(1):303-9.

Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20.

Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.

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
Last Update Posted:	September 19, 2008
Last Verified:	September 2008

Keywords provided by University of Washington:

Male contraception; testosterone; acyline

Additional relevant MeSH terms:

Testosterone; Testosterone enanthate; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone; Androgens; Hormones	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