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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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 |
- Intratesticular hormone levels [ Time Frame: One year ]
- sperm count levels [ Time Frame: One year ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts 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

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
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | William Bremner, MD | University of Washington |
Publications of Results:
Other Publications:
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 |
Male contraception Testosterone |
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 |