Male Hormonal Contraceptive Development-ACY-5

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00161447

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), CONRAD (Other)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Acyline Drug: Testosterone Gel Drug: Depo-Medroxyprogesterone	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Testim Drug: Depo-Medroxyprogesterone DMPA (injected into muscle) Day 0 & month 3 Other Names: 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 Names: Testim Drug: Depo-Medroxyprogesterone DMPA (injected into muscle) Day 0 & month 3 Other Names: DMPA

Arm

Intervention/Treatment

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 Names:

Testim

Drug: Depo-Medroxyprogesterone

DMPA (injected into muscle) Day 0 & month 3

Other Names:

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 Names:

Testim

Drug: Depo-Medroxyprogesterone

DMPA (injected into muscle) Day 0 & month 3

Other Names:

DMPA

Outcome Measures

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 [One year]