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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161486
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 19, 2008
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypogonadism Contraception Drug: Testosterone gel Drug: Acyline Drug: Placebo acyline Drug: Placebo Testosterone gel Phase 1

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1
Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily 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

Active Comparator: 2
Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks
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

Active Comparator: 3
Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks
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




Primary Outcome Measures :
  1. Intervention trial to examine the hormonal regulation of prostate gene expression and tissue hormone levels, tissue protein expression and apoptosis. [ Time Frame: 28-days ]

Secondary Outcome Measures :
  1. Cellular immune function [ Time Frame: 28-days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: William J Bremner, MD University of Washington
Additional Information:
Publications of Results:
Other Publications:

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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
Keywords provided by University of Washington:
Male contraception
Prostate
Acyline
Androgen replacement
Additional relevant MeSH terms:
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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