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Manipulation of the Intratesticular Hormonal Milieu with Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum - Article


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Depo-provera

Clinical Trial: Manipulation of the Intratesticular Hormonal Milieu with Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum

This study is no longer recruiting patients.

Sponsors and Collaborators: University of Washington
National Institute of Child Health and Human Development (NICHD)
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00156650

Purpose

This study is being offered to all particpants of the ACY-5 study as an optional addition to the male contraceptive study in which they participate. Participation is voluntary.

The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.

Condition Intervention Phase
Contraception
  Drug: Acyline
 Drug: Testosterone Gel
 Drug: Depo-Medroxyprogesterone
 Phase I
Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title: Male Hormonal Contraception Development: Suppression of Spermatogenesis with the Addition of a Potent GnRH Antagonist (Acyline) to Testosterone and DMPA (ACY-5) -Sub-Study (HOP 5)

Further Study Details: 
Primary Outcomes: Intratesticular hormone levels and sperm count
Expected Total Enrollment:  24

Study start: December 2004;  Study completion: December 2005
Last follow-up: July 2005;  Data entry closure: August 2005

The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all individuals enrolled achieve azoospermia (zero sprem). However, early data demonstrated that some individuals have persistent sperm in their semen despite treatment. We hope to be able to determine whether differences in intratesticular hormone levels account for persistent sperm production in men who do not reach counts of zero as compared to those who do in the male contraceptive study. This study will measure testosterone levels in the testes of men who are participating in male contraceptive studies. Testosterone will be measured in a small amount of testicular fluid at the end of the study treatment phase after sperm counts have been reduced to zero or very low levels.

Eligibility

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Male between 18-55, in good health, with normal sperm counts and willing to use an acceptable form of contraception during the study

Exclusion Criteria:

  • Male in poor health, significant chronic or acute medical illness, skin conditions that might interfere with or be exacerbated by testosterone gel, know history of alcohol, illicit drug or anabolic steroid abuse, abnormal reproductive function, participation in a long-term male contraceptive study within three months of screening

Location Information


Washington
      University of Washington, Seattle,  Washington,  98195,  United States

Study chairs or principal investigators

William Bremner, MD,  Principal Investigator,  University of Washington   

More Information

http://depts.washington.edu/popctr/

Publications

Coviello AD, Bremner WJ, Matsumoto AM, Herbst KL, Amory JK, Anawalt BD, Yan X, Brown TR, Wright WW, Zirkin BR, Jarow JP. Intratesticular testosterone concentrations comparable with serum levels are not sufficient to maintain normal sperm production in men receiving a hormonal contraceptive regimen. J Androl. 2004 Nov-Dec;25(6):931-8.

Coviello AD, Matsumoto AM, Bremner WJ, Herbst KL, Amory JK, Anawalt BD, Sutton PR, Wright WW, Brown TR, Yan X, Zirkin BR, Jarow JP. Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression. J Clin Endocrinol Metab. 2005 May;90(5):2595-602. Epub 2005 Feb 15.

Study ID Numbers:  04-0832-D-substudy
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156650
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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Page Updated: October 3, 2005
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