Male Hormonal Contraceptive Development-ACY-5

NCT00161447 | Completed Phase 1

• 2 other identifiers: 04-0832-DU54HD042454
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contraception

Keywords

Male contraception; testosterone; acyline

Outcome Measures

Primary Outcomes (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

  One year

Secondary Outcomes (1)

• Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels

  One year

Study Arms (2)

1

ACTIVE COMPARATOR

Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3

Drug: Testosterone Gel; Drug: Depo-Medroxyprogesterone

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; Drug: Testosterone Gel; Drug: Depo-Medroxyprogesterone

Interventions

Acyline DRUG

Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks

2

Testosterone Gel DRUG

Testosterone Gel (10 g daily

Also known as: Testim

1; 2

Depo-Medroxyprogesterone DRUG

DMPA (injected into muscle) Day 0 \& month 3

Also known as: DMPA

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males between 18-55
• In good general health
• With normal sperm counts
• Willing to use an acceptable form of contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• CONRAD: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (8)

• 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. doi: 10.1093/humrep/13.5.1225.

  PMID: 9647551 BACKGROUND

• 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.

  PMID: 10386821 BACKGROUND

• 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. doi: 10.1210/jcem.86.1.7057.

  PMID: 11232016 BACKGROUND

• 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. doi: 10.1210/jcem.87.7.8675.

  PMID: 12107227 BACKGROUND

• 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.

  PMID: 1977002 BACKGROUND

• 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. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.

  PMID: 16940442 RESULT

• 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. doi: 10.1016/j.contraception.2006.11.003. Epub 2007 Jan 16.

  PMID: 17303493 RESULT

• 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. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.

  PMID: 17494097 RESULT

MeSH Terms

Interventions

acyline; Testosterone; Medroxyprogesterone Acetate; N,N-dimethyl-4-anisidine

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes

Study Officials

• William J Bremner, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: September 19, 2008

Record last verified: 2008-09

Locations

US (1)