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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2004

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.

Intervention(s) in this Clinical Trial

• Drug: Testosterone gel
  • Testosterone gel 100 mg daily for 4 weeks
• Drug: Acyline
  • Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks
• Drug: Placebo acyline
  • Placebo acyline injections every two weeks (2 doses)
• Drug: Placebo Testosterone gel
  • placebo testosterone gel daily for 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks
• Active Comparator: 2
  • Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks
• Active Comparator: 3
  • Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks

Primary Measures

• Intervention trial to examine the hormonal regulation of prostate gene expression and tissue hormone levels, tissue protein expression and apoptosis.
  • Time Frame: 28-days
    Safety Issue?: No

Secondary Measures

• Cellular immune function
  • Time Frame: 28-days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Washington

Overall Clinical Trial Officials and Contacts

William J Bremner, MD Principal Investigator University of Washington  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00161486

Study ID Number: 03-9401-B

ClinicalTrials.gov Identifier: NCT00161486

Health Authority: United States: Food and Drug Administration

http://depts.washington.edu/popctr