The Effects of Testosterone on Prostate Tissue (ACYP-1)

Study Overview
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Brief Summary
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The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

Detailed Description
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We will be administering two drugs: Testim (testosterone gel) and Acyline. Acyline is an experimental drug. We want to see their effects on levels of hormones in the blood and prostate. In addition, we will be examining the effects of these drugs on the expression of genes within the prostate. Acyline suppresses LH and FSH, which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore, Acyline blocks testosterone production. In preliminary studies, a single injection of Acyline reversibly lowered the FSH, LH and testosterone levels in the blood for approximately 15 days. Prolonged low levels of LH and FSH cause suppression of sperm production in normal men. However, men may experience some side effects from the low levels of testosterone caused by acyline, thus exogenous testosterone is required to sustain normal male androgen and organ effects without suppressing spermatogenesis. This combination of drugs is a promising male contraceptive regimen. In addition, millions of older men are using testosterone replacement to treat male andropause; low level testosterone associated with aging. However, the effect of testosterone on the prostate is unknown. Studies examining the effect of testosterone on the prostate are needed.

Official Title
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The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1)

Conditions
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Hypogonadism, Contraception

Intervention / Treatment
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* Drug: Testosterone gel
* Drug: Acyline
* Drug: Placebo acyline
* Drug: Placebo Testosterone gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males between 35 and 55, normal serum testosterone levels, normal gonadal function Exclusion Criteria: History of prostate cancer, PSA>2.0, AUA BPH symptom score >10, History of testosterone or anabolic steroid use, chronic medical illness or prostate disease, active serious infection or immunosuppression, history of a bleeding disorder or need for anticoagulation, abnormal digital rectal exam, abnormal prostate ultrasound, first degree relative with history of prostate cancer

Ages Eligible for Study
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Minimum Age: 35 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks | Drug: Placebo acyline<br>* Placebo acyline injections every two weeks (2 doses)<br>Drug: Placebo Testosterone gel<br>* placebo testosterone gel daily for 4 weeks<br>|
| Active Comparator: 2<br>Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks | Drug: Acyline<br>* Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks<br>Drug: Placebo Testosterone gel<br>* placebo testosterone gel daily for 4 weeks<br>|
| Active Comparator: 3<br>Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks | Drug: Testosterone gel<br>* Testosterone gel 100 mg daily for 4 weeks<br>* Other names: Testim;Drug: Acyline<br>* Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention trial to examine the hormonal regulation of prostate gene expression and tissue hormone levels, tissue protein expression and apoptosis. |  | 28-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular immune function |  | 28-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male contraception, Prostate, Acyline, Androgen replacement