Male Hormonal Contraceptive Development-ACY-5

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

Detailed Description
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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.

Official Title
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Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)

Conditions
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Contraception

Intervention / Treatment
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* Drug: Acyline
* Drug: Testosterone Gel
* Drug: Depo-Medroxyprogesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3 | Drug: Testosterone Gel<br>* Testosterone Gel (10 g daily<br>* Other names: Testim;Drug: Depo-Medroxyprogesterone<br>* DMPA (injected into muscle) Day 0 & month 3<br>* Other names: DMPA;|
| Active Comparator: 2<br>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<br>* Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks<br>Drug: Testosterone Gel<br>* Testosterone Gel (10 g daily<br>* Other names: Testim;Drug: Depo-Medroxyprogesterone<br>* DMPA (injected into muscle) Day 0 & month 3<br>* Other names: DMPA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acyline, Male contraception, testosterone