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

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:

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

Publications:

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.

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, U54 HD42454
Study First Received:	September 8, 2005
Last Updated:	September 18, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:


Male contraception testosterone acyline

Additional relevant MeSH terms:


Methyltestosterone Testosterone Testosterone 17 beta-cypionate Testosterone enanthate Testosterone undecanoate Anabolic Agents Androgens	Antineoplastic Agents Antineoplastic Agents, Hormonal Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015