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

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

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Medroxyprogesterone acetate Testosterone enanthate Testosterone undecanoate

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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. Epub 2007 May 9.

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.


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:


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

ClinicalTrials.gov processed this record on March 03, 2015

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