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
Summary
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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
- 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
screening
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
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