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Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Acyline (Drug); Testosterone Gel (Drug); Depo-Medroxyprogesterone (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
William Bremner, MD, Principal Investigator, Affiliation: University of Washington


This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. 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.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Intratesticular hormone levels

Secondary outcome: sperm count levels

Detailed description: The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all individuals enrolled achieve azoospermia (zero sperm). 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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.


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

- No history of alcohol, illicit drug or anabolic steroid abuse

- Abnormal reproductive function

- Participation in a long-term male contraceptive study within three months of


Locations and Contacts

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

University of Washington

Related 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.

Starting date: December 2004
Last updated: September 18, 2008

Page last updated: August 23, 2015

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