Male Hormonal Contraceptive Development-ACY-5 - Full Text View

Sponsors and Collaborators:	University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) CONRAD
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00161447

Purpose

The purpose of this research study is to help in the development of male contraception (birth control).

Condition	Intervention	Phase
Contraception	Drug: Acyline Drug: Testosterone Gel Drug: Depo-Medroxyprogesterone	Phase I Phase II

MedlinePlus related topics: Birth Control

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Medroxyprogesterone Medroxyprogesterone 17-acetate Acyline

U.S. FDA Resources

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)

Further study details as provided by University of Washington:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels [ Time Frame: One year ] [ Designated as safety issue: No ]

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
1: Active Comparator 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 Drug: Depo-Medroxyprogesterone DMPA (injected into muscle) Day 0 & month 3
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	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

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161447

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

http://depts.washington.edu/popctr This link exits the ClinicalTrials.gov site

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 Aug 29; [Epub ahead of print]

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, Ploger 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.

[No authors listed] 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:	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

Keywords provided by University of Washington:

Male contraception
testosterone
acyline

Study placed in the following topic categories:

Testosterone
Medroxyprogesterone 17-Acetate
Medroxyprogesterone
Methyltestosterone
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009