Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum

Study Overview
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Brief Summary
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This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. Participation is voluntary. The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.

Detailed Description
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The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all individuals enrolled achieve azoospermia (zero sperm). However, early data demonstrated that some individuals have persistent sperm in their semen despite treatment. We hope to be able to determine whether differences in intratesticular hormone levels account for persistent sperm production in men who do not reach counts of zero as compared to those who do in the male contraceptive study. This study will measure testosterone levels in the testes of men who are participating in male contraceptive studies. Testosterone will be measured in a small amount of testicular fluid at the end of the study treatment phase after sperm counts have been reduced to zero or very low levels.

Official Title
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Male Hormonal Contraception Development: Suppression of Spermatogenesis With the Addition of a Potent GnRH Antagonist (Acyline) to Testosterone and DMPA (ACY-5) -Sub-Study (HOP 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: Male between 18-55 In good health With normal sperm counts and willing to use an acceptable form of contraception during the study Exclusion Criteria: Male in poor health Significant chronic or acute medical illness Skin conditions that might interfere with or be exacerbated by testosterone gel No history of alcohol, illicit drug or anabolic steroid abuse Abnormal reproductive function Participation in a long-term male contraceptive study within three months of screening

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 (Depo-Medroxyprogesterone) (injected into muscle Day 0 & at Month 3) | Drug: Testosterone Gel<br>* Testosterone (T) gel 10 g daily for 6 months<br>* Other names: Testim;Drug: Depo-Medroxyprogesterone<br>* 300 mg IM every 3 months<br>* Other names: DMPA;|
| Active Comparator: 2<br>T gel for 6 months + DMPA (Day 0 & Month 3) + Acyline 300 mcg/kg twice monthly for 12 weeks | Drug: Acyline<br>* Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks<br>Drug: Testosterone Gel<br>* Testosterone (T) gel 10 g daily for 6 months<br>* Other names: Testim;Drug: Depo-Medroxyprogesterone<br>* 300 mg IM every 3 months<br>* Other names: DMPA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intratesticular hormone levels |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm count levels |  | One year | 

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