Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]

This study has been completed.

Study NCT00490022 Information provided by University of Washington

First Received on June 20, 2007. Last Updated on June 20, 2011 History of Changes

Results First Received: January 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Healthy
Interventions:	Drug: Dihydrotestosterone (DHT) gel (0.7%) Drug: Placebo gel

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Up to 55 normal, healthy men between the ages of 35-55 will be recruited for this study. All subject activities will occur at the University of Washington in Seattle Washington.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects must meet all study protocol inclusion criteria such as informed consent, normal lab values, normal physical examination and normal prostate ultrasound, and not have exclusion criteria such as a first degree relative with or personal history of prostate cancer, PSA >2.0 or a history of a bleeding disorder or need for anticoagulation.

Reporting Groups

	Description
Placebo DHT Gel	Placebo gel for one month
DHT Gel	DHT gel (70 mg/day) for one month

Participant Flow: Overall Study

	Placebo DHT Gel	DHT Gel
STARTED	16	15
COMPLETED	15	12
NOT COMPLETED	1	3
Adverse Event	0	2
Withdrawal by Subject	1	0
Subject failed to disclose concommitant	0	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo DHT Gel	Placebo gel for one month
DHT Gel	DHT gel (70 mg/day) for one month

Baseline Measures

	Placebo DHT Gel	DHT Gel	Total
Number of Participants [units: participants]	16	15	31
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	16	15	31
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	44.4 ± 6.7	42.7 ± 1.6	43.6 ± 4.2
Gender [units: participants]
Female	0	0	0
Male	16	15	31
Region of Enrollment [units: participants]
United States	16	15	31

Outcome Measures

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1. Primary:

Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel. [ Time Frame: 28-days ]

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2. Secondary:

Prostate Epithelial Cell Proliferation [ Time Frame: 28-days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Stephanie Page, PhD, MD
Organization: University of Washington
phone: 206.616.0483
e-mail: page@u.washington.edu

Publications:

Huggins C, Hodges CV. Studies on prostatic cancer: I. The effect of castration, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. 1941. J Urol. 2002 Jul;168(1):9-12. No abstract available.

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. No abstract available.

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, 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.

Wu FC, von Eckardstein A. Androgens and coronary artery disease. Endocr Rev. 2003 Apr;24(2):183-217. Review.

Bagatell CJ, Heiman JR, Matsumoto AM, Rivier JE, Bremner WJ. Metabolic and behavioral effects of high-dose, exogenous testosterone in healthy men. J Clin Endocrinol Metab. 1994 Aug;79(2):561-7.

Bartsch W, Klein H, Schiemann U, Bauer HW, Voigt KD. Enzymes of androgen formation and degradation in the human prostate. Ann N Y Acad Sci. 1990;595:53-66. Review. No abstract available.

Bartsch W, Krieg M, Becker H, Mohrmann J, Voigt KD. Endogenous androgen levels in epithelium and stroma of human benign prostatic hyperplasia and normal prostate. Acta Endocrinol (Copenh). 1982 Aug;100(4):634-40.

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. Epub 2006 Aug 1.

Wilson JD. The role of 5alpha-reduction in steroid hormone physiology. Reprod Fertil Dev. 2001;13(7-8):673-8. Review.

Andriole GL, Humphrey P, Ray P, Gleave ME, Trachtenberg J, Thomas LN, Lazier CB, Rittmaster RS. Effect of the dual 5alpha-reductase inhibitor dutasteride on markers of tumor regression in prostate cancer. J Urol. 2004 Sep;172(3):915-9.

Norman RW, Coakes KE, Wright AS, Rittmaster RS. Androgen metabolism in men receiving finasteride before prostatectomy. J Urol. 1993 Nov;150(5 Pt 2):1736-9.

Kunelius P, Lukkarinen O, Hannuksela ML, Itkonen O, Tapanainen JS. The effects of transdermal dihydrotestosterone in the aging male: a prospective, randomized, double blind study. J Clin Endocrinol Metab. 2002 Apr;87(4):1467-72.

Ly LP, Jimenez M, Zhuang TN, Celermajer DS, Conway AJ, Handelsman DJ. A double-blind, placebo-controlled, randomized clinical trial of transdermal dihydrotestosterone gel on muscular strength, mobility, and quality of life in older men with partial androgen deficiency. J Clin Endocrinol Metab. 2001 Sep;86(9):4078-88.

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.

Publications automatically indexed to this study:

Page ST, Lin DW, Mostaghel EA, Marck BT, Wright JL, Wu J, Amory JK, Nelson PS, Matsumoto AM. Dihydrotestosterone administration does not increase intraprostatic androgen concentrations or alter prostate androgen action in healthy men: a randomized-controlled trial. J Clin Endocrinol Metab. 2011 Feb;96(2):430-7. Epub 2010 Dec 22.

Responsible Party:	Stephanie T Page, MD, PhD, University of Washington
ClinicalTrials.gov Identifier:	NCT00490022 History of Changes
Other Study ID Numbers:	31866-A, 1K23AG027238-01A1
Study First Received:	June 20, 2007
Results First Received:	January 10, 2011
Last Updated:	June 20, 2011
Health Authority:	United States: Food and Drug Administration