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
  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:


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
CONRAD
Investigators
Principal Investigator: William J Bremner, MD, PhD University of Washington
  More Information

Additional Information:
Publications:

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:
Reproductive Control Agents
Contraceptive Agents, Male
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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 18, 2014