Male Hormonal Contraceptive Development-ACY-5 (ACY-5)
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| ClinicalTrials.gov Identifier: NCT00161447 |
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Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : September 19, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Contraception | Drug: Acyline Drug: Testosterone Gel Drug: Depo-Medroxyprogesterone | Phase 1 Phase 2 |
The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone (T) and the progestin depo-medroxyprogesterone acetate (DMPA).
We will be administering combinations of three drugs: Testosterone (T) by gel, Depot Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The T/DMPA/Acyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis.
In prior studies with testosterone and DMPA these drug, which are hormones, have been found to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to improve this to 100% of men by adding another drug, Acyline.
Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of spermatogenesis to zero (azoospermia) by the end of the treatment phase.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5) |
| Study Start Date : | May 2004 |
| Actual Primary Completion Date : | April 2006 |
| Actual Study Completion Date : | April 2006 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
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Drug: Testosterone Gel
Testosterone Gel (10 g daily
Other Name: Testim Drug: Depo-Medroxyprogesterone DMPA (injected into muscle) Day 0 & month 3
Other Name: DMPA |
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Active Comparator: 2
Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 & at month 3) + Acyline (SQ) every two weeks for the first 12 weeks
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Drug: Acyline
Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks Drug: Testosterone Gel Testosterone Gel (10 g daily
Other Name: Testim Drug: Depo-Medroxyprogesterone DMPA (injected into muscle) Day 0 & month 3
Other Name: DMPA |
- The primary biological end points in this trial will be suppression of spermatogenesis and gonadotropins while monitoring for any adverse changes in lipid metabolism, sexual side effects or in general health [ Time Frame: One year ]
- Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels [ Time Frame: One year ]
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Males between 18-55
- In good general health
- With normal sperm counts
- Willing to use an acceptable form of contraception
Exclusion Criteria:
- Men in poor health
- Significant chronic or acute medical illness
- Skin conditions that might interfere with or be exacerbated by testosterone gel
- Known history of alcohol, illicit drug or anabolic steroid abuse
- Abnormal reproductive function
- Participation in a long-term male contraceptive study within past three months
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): NCT00161447
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | William J Bremner, MD, PhD | University of Washington |
Publications of Results:
Other Publications:
| Responsible Party: | William J Bremner, MD, PhD, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00161447 |
| Other Study ID Numbers: |
04-0832-D U54HD042454 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 12, 2005 Key Record Dates |
| Last Update Posted: | September 19, 2008 |
| Last Verified: | September 2008 |
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Male contraception testosterone acyline |
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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 |