The Effects of Testosterone on Prostate Tissue (ACYP-1)
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism; Contraception
Intervention: Testosterone gel (Drug); Acyline (Drug); Placebo acyline (Drug); Placebo Testosterone gel (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
William J Bremner, MD, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Intervention trial to examine the hormonal regulation of prostate gene expression and tissue hormone levels, tissue protein expression and apoptosis.
Secondary outcome: Cellular immune function
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.
Eligibility
Minimum age: 35 Years.
Maximum age: 55 Years.
Gender(s): Male.
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
Locations and Contacts
University of Washington, Seattle, Washington 98195, United States
Additional Information
http://depts.washington.edu/popctr
Related publications: 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. Review. 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. Schatzl G, Madersbacher S, Thurridl T, Waldmüller 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. 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. Epub 2002 Aug 16. 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. 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. 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. 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.
Starting date: July 2004
Last updated: September 18, 2008
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