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

Primary Purpose

Hypogonadism, Contraception

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Testosterone gel
Acyline
Placebo acyline
Placebo Testosterone gel
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Male contraception, Prostate, Acyline, Androgen replacement

Eligibility Criteria

35 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks

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

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

Outcomes

Primary Outcome Measures

Intervention trial to examine the hormonal regulation of prostate gene expression and tissue hormone levels, tissue protein expression and apoptosis.

Secondary Outcome Measures

Cellular immune function

Full Information

First Posted
September 8, 2005
Last Updated
September 18, 2008
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00161486
Brief Title
The Effects of Testosterone on Prostate Tissue (ACYP-1)
Acronym
ACYP-1
Official Title
The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Contraception
Keywords
Male contraception, Prostate, Acyline, Androgen replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks
Arm Title
3
Arm Type
Active Comparator
Arm Description
Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Testosterone gel
Other Intervention Name(s)
Testim
Intervention Description
Testosterone gel 100 mg daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Acyline
Intervention Description
Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo acyline
Intervention Description
Placebo acyline injections every two weeks (2 doses)
Intervention Type
Drug
Intervention Name(s)
Placebo Testosterone gel
Intervention Description
placebo testosterone gel daily for 4 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Cellular immune function
Time Frame
28-days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Bremner, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12721204
Citation
Bhasin S, Singh AB, Mac RP, Carter B, Lee MI, Cunningham GR. Managing the risks of prostate disease during testosterone replacement therapy in older men: recommendations for a standardized monitoring plan. J Androl. 2003 May-Jun;24(3):299-311. doi: 10.1002/j.1939-4640.2003.tb02676.x. No abstract available.
Results Reference
background
PubMed Identifier
8968017
Citation
Morgentaler A, Bruning CO 3rd, DeWolf WC. Occult prostate cancer in men with low serum testosterone levels. JAMA. 1996 Dec 18;276(23):1904-6.
Results Reference
background
PubMed Identifier
11304729
Citation
Schatzl G, Madersbacher S, Thurridl T, Waldmuller J, Kramer G, Haitel A, Marberger M. High-grade prostate cancer is associated with low serum testosterone levels. Prostate. 2001 Apr;47(1):52-8. doi: 10.1002/pros.1046.
Results Reference
background
PubMed Identifier
12185249
Citation
Nelson PS, Clegg N, Arnold H, Ferguson C, Bonham M, White J, Hood L, Lin B. The program of androgen-responsive genes in neoplastic prostate epithelium. Proc Natl Acad Sci U S A. 2002 Sep 3;99(18):11890-5. doi: 10.1073/pnas.182376299. Epub 2002 Aug 16.
Results Reference
background
PubMed Identifier
12107227
Citation
Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20. doi: 10.1210/jcem.87.7.8675.
Results Reference
background
PubMed Identifier
8345047
Citation
Bagatell CJ, Matsumoto AM, Christensen RB, Rivier JE, Bremner WJ. Comparison of a gonadotropin releasing-hormone antagonist plus testosterone (T) versus T alone as potential male contraceptive regimens. J Clin Endocrinol Metab. 1993 Aug;77(2):427-32. doi: 10.1210/jcem.77.2.8345047.
Results Reference
background
PubMed Identifier
9768659
Citation
Swerdloff RS, Bagatell CJ, Wang C, Anawalt BD, Berman N, Steiner B, Bremner WJ. Suppression of spermatogenesis in man induced by Nal-Glu gonadotropin releasing hormone antagonist and testosterone enanthate (TE) is maintained by TE alone. J Clin Endocrinol Metab. 1998 Oct;83(10):3527-33. doi: 10.1210/jcem.83.10.5184.
Results Reference
background
PubMed Identifier
1639948
Citation
Tom L, Bhasin S, Salameh W, Steiner B, Peterson M, Sokol RZ, Rivier J, Vale W, Swerdloff RS. Induction of azoospermia in normal men with combined Nal-Glu gonadotropin-releasing hormone antagonist and testosterone enanthate. J Clin Endocrinol Metab. 1992 Aug;75(2):476-83. doi: 10.1210/jcem.75.2.1639948.
Results Reference
background
PubMed Identifier
16352669
Citation
Page ST, Plymate SR, Bremner WJ, Matsumoto AM, Hess DL, Lin DW, Amory JK, Nelson PS, Wu JD. Effect of medical castration on CD4+ CD25+ T cells, CD8+ T cell IFN-gamma expression, and NK cells: a physiological role for testosterone and/or its metabolites. Am J Physiol Endocrinol Metab. 2006 May;290(5):E856-63. doi: 10.1152/ajpendo.00484.2005. Epub 2005 Dec 13.
Results Reference
result
PubMed Identifier
16882745
Citation
Page ST, Lin DW, Mostaghel EA, Hess DL, True LD, Amory JK, Nelson PS, Matsumoto AM, Bremner WJ. Persistent intraprostatic androgen concentrations after medical castration in healthy men. J Clin Endocrinol Metab. 2006 Oct;91(10):3850-6. doi: 10.1210/jc.2006-0968. Epub 2006 Aug 1.
Results Reference
result
PubMed Identifier
17510436
Citation
Mostaghel EA, Page ST, Lin DW, Fazli L, Coleman IM, True LD, Knudsen B, Hess DL, Nelson CC, Matsumoto AM, Bremner WJ, Gleave ME, Nelson PS. Intraprostatic androgens and androgen-regulated gene expression persist after testosterone suppression: therapeutic implications for castration-resistant prostate cancer. Cancer Res. 2007 May 15;67(10):5033-41. doi: 10.1158/0008-5472.CAN-06-3332.
Results Reference
result
Links:
URL
http://depts.washington.edu/popctr/
Description
http://depts.washington.edu/popctr

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

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