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

Phase 1

Completed

• Conditions: Hypogonadism; Contraception
• Interventions: Drug: Placebo acyline; Drug: Testosterone gel; Drug: Acyline; Drug: Placebo Testosterone gel

• Registration Number: NCT00161486
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-18
• Last Update Posted: 2008-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo acyline	Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks
1	Placebo Testosterone gel	Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks
2	Placebo Testosterone gel	Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks
3	Testosterone gel	Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks
2	Acyline	Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks
3	Acyline	Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cellular immune function	28-days

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States