The Effects of Testosterone on Prostate Tissue (ACYP-1) (ACYP-1)
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| ClinicalTrials.gov Identifier: NCT00161486 |
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Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : September 19, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypogonadism Contraception | Drug: Testosterone gel Drug: Acyline Drug: Placebo acyline Drug: Placebo Testosterone gel | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1) |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | November 2004 |
| Actual Study Completion Date : | November 2004 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 1
Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks
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Drug: Placebo acyline
Placebo acyline injections every two weeks (2 doses) Drug: Placebo Testosterone gel placebo testosterone gel daily for 4 weeks |
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Active Comparator: 2
Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks
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Drug: Acyline
Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks Drug: Placebo Testosterone gel placebo testosterone gel daily for 4 weeks |
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Active Comparator: 3
Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks
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Drug: Testosterone gel
Testosterone gel 100 mg daily for 4 weeks
Other Name: Testim Drug: Acyline Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks |
- Intervention trial to examine the hormonal regulation of prostate gene expression and tissue hormone levels, tissue protein expression and apoptosis. [ Time Frame: 28-days ]
- Cellular immune function [ Time Frame: 28-days ]
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| Ages Eligible for Study: | 35 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161486
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | William J Bremner, MD | University of Washington |
Publications of Results:
Other Publications:
| Responsible Party: | William J Bremner, MD, PhD, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00161486 |
| Other Study ID Numbers: |
03-9401-B U 54 HD42454 |
| First Posted: | September 12, 2005 Key Record Dates |
| Last Update Posted: | September 19, 2008 |
| Last Verified: | September 2008 |
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Male contraception Prostate Acyline Androgen replacement |
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Hypogonadism Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate Acyline |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents Hormone Antagonists |