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

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)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00156650

Acronym

IHOP-5

Enrollment

Registered

2005-09-12

Start date

2004-12-31

Completion date

2005-07-31

Last updated

2008-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Male contraception, Testosterone

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.

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.

Interventions

DRUGAcyline

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

DRUGTestosterone Gel

Testosterone (T) gel 10 g daily for 6 months

DRUGDepo-Medroxyprogesterone

300 mg IM every 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Intratesticular hormone levels	One year

Secondary

Measure	Time frame
sperm count levels	One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026