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

NCT ID: NCT00156650

Last Updated: 2008-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Contraception

Keywords

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Male contraception Testosterone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Testosterone (T) gel for 6 months + DMPA (Depo-Medroxyprogesterone) (injected into muscle Day 0 \& at Month 3)

Group Type ACTIVE_COMPARATOR

Testosterone Gel

Intervention Type DRUG

Testosterone (T) gel 10 g daily for 6 months

Depo-Medroxyprogesterone

Intervention Type DRUG

300 mg IM every 3 months

2

T gel for 6 months + DMPA (Day 0 \& Month 3) + Acyline 300 mcg/kg twice monthly for 12 weeks

Group Type ACTIVE_COMPARATOR

Acyline

Intervention Type DRUG

Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks

Testosterone Gel

Intervention Type DRUG

Testosterone (T) gel 10 g daily for 6 months

Depo-Medroxyprogesterone

Intervention Type DRUG

300 mg IM every 3 months

Interventions

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Acyline

Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks

Intervention Type DRUG

Testosterone Gel

Testosterone (T) gel 10 g daily for 6 months

Intervention Type DRUG

Depo-Medroxyprogesterone

300 mg IM every 3 months

Intervention Type DRUG

Other Intervention Names

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Testim DMPA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Principal Investigators

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William Bremner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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. doi: 10.1002/j.1939-4640.2004.tb03164.x.

Reference Type BACKGROUND
PMID: 15477366 (View on PubMed)

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. doi: 10.1210/jc.2004-0802. Epub 2005 Feb 15.

Reference Type BACKGROUND
PMID: 15713727 (View on PubMed)

Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.

Reference Type RESULT
PMID: 17494097 (View on PubMed)

Other Identifiers

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U54HD042454

Identifier Type: NIH

Identifier Source: secondary_id

View Link

04-0832-D-substudy

Identifier Type: -

Identifier Source: org_study_id