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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00156650
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 19, 2008
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Washington

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Contraception Drug: Acyline Drug: Testosterone Gel Drug: Depo-Medroxyprogesterone Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Testosterone (T) gel for 6 months + DMPA (Depo-Medroxyprogesterone) (injected into muscle Day 0 & at Month 3)
 Drug: Testosterone Gel
Testosterone (T) gel 10 g daily for 6 months
Other Name: Testim

Drug: Depo-Medroxyprogesterone
300 mg IM every 3 months
Other Name: DMPA
Active Comparator: 2
T gel for 6 months + DMPA (Day 0 & Month 3) + Acyline 300 mcg/kg twice monthly for 12 weeks
 Drug: Acyline
Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks

Drug: Testosterone Gel
Testosterone (T) gel 10 g daily for 6 months
Other Name: Testim

Drug: Depo-Medroxyprogesterone
300 mg IM every 3 months
Other Name: DMPA


Outcome Measures
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Primary Outcome Measures :
  1. Intratesticular hormone levels [ Time Frame: One year ]

Secondary Outcome Measures :
  1. sperm count levels [ Time Frame: One year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156650


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: William Bremner, MD University of Washington
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: William J Bremner, MD, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00156650    
Other Study ID Numbers: 04-0832-D-substudy
U54HD042454 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008
Keywords provided by University of Washington:
Male contraception
Testosterone
Additional relevant MeSH terms:
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Medroxyprogesterone Acetate
Medroxyprogesterone
Testosterone
Acyline
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Hormone Antagonists