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

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00156650
First received: September 8, 2005
Last updated: September 18, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention Phase
Contraception
 Drug: Acyline
Drug: Testosterone Gel
Drug: Depo-Medroxyprogesterone
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Intratesticular hormone levels [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sperm count levels [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: December 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156650

Locations
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
Principal Investigator: William Bremner, MD University of Washington
  More Information

Additional Information:
University of Washington  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: William J Bremner, MD, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00156650     History of Changes
Other Study ID Numbers: 04-0832-D-substudy, U54 HD42454
Study First Received: September 8, 2005
Last Updated: September 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Male contraception
Testosterone

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Medroxyprogesterone Acetate
Medroxyprogesterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on May 16, 2013