Male Hormonal Contraceptive Development-ACY-5

This study has been completed.
Sponsor:
Collaborators:
CONRAD
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00161447
First received: September 8, 2005
Last updated: September 18, 2008
Last verified: September 2008

September 8, 2005
September 18, 2008
May 2004
April 2006   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00161447 on ClinicalTrials.gov Archive Site
Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels [ Time Frame: One year ] [ Designated as safety issue: No ]
Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels
Not Provided
Not Provided
 
Male Hormonal Contraceptive Development-ACY-5
Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
  • 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
  • Active Comparator: 1
    Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
    Interventions:
    • Drug: Testosterone Gel
    • Drug: Depo-Medroxyprogesterone
  • 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
    Interventions:
    • Drug: Acyline
    • Drug: Testosterone Gel
    • Drug: Depo-Medroxyprogesterone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161447
04-0832-D, U54 HD42454
No
William J Bremner, MD, PhD, University of Washington
University of Washington
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • CONRAD
Principal Investigator: William J Bremner, MD, PhD University of Washington
University of Washington
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP