Expired Study
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Seattle, Washington 98195


Purpose:

The purpose of this research study is to help in the development of male contraception (birth control).


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

04-0832-D


NCT ID:

NCT00161447


Secondary ID:

U54 HD42454


Study Acronym:

ACY-5


Brief Title:

Male Hormonal Contraceptive Development-ACY-5


Official Title:

Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

43


Enrollment Type:

Actual


Overall Contact Information

Official Name:William J Bremner, MD, PhD
Principal Investigator
University of Washington

Study Dates

Start Date:May 2004
Completion Date:April 2006
Completion Type:Actual
Primary Completion Date:April 2006
Primary Completion Type:Actual
Verification Date:September 2008
Last Changed Date:September 18, 2008
First Received Date:September 8, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels
Time Frame:One year
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Acyline
Description:Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
Arm Name:2
Intervention Type:Drug
Name:Testosterone Gel
Description:Testosterone Gel (10 g daily
Arm Name:1
Other Name:Testim
Intervention Type:Drug
Name:Depo-Medroxyprogesterone
Description:DMPA (injected into muscle) Day 0 & month 3
Arm Name:1
Other Name:DMPA

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
Study Arm Type:Active Comparator
Arm Name:2
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Meriggiola MC, Bremner WJ, Costantino A, Di Cintio G, Flamigni C. Low dose of cyproterone acetate and testosterone enanthate for contraception in men. Hum Reprod. 1998 May;13(5):1225-9.
PMID:9647551
Reference Type:Reference
Citation:Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
PMID:10386821
Reference Type:Reference
Citation:Kamischke A, Venherm S, Ploger D, von Eckardstein S, Nieschlag E. Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab. 2001 Jan;86(1):303-9.
PMID:11232016
Reference Type:Reference
Citation:Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20.
PMID:12107227
Reference Type:Reference
Citation:[No authors listed] Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.
PMID:1977002
Reference Type:Results Reference
Citation:Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. TESTOSTERONE GEL COMBINED WITH DEPOMEDROXYPROGESTERONE ACETATE IS AN EFFECTIVE MALE HORMONAL CONTRACEPTIVE REGIMEN AND IS NOT ENHANCED BY THE ADDITION OF A GnRH ANTAGONIST. J Clin Endocrinol Metab. 2006 Aug 29; [Epub ahead of print]
PMID:16940442
Reference Type:Results Reference
Citation:Amory JK, Page ST, Anawalt BD, Matsumoto AM, Bremner WJ. Acceptability of a combination testosterone gel and depomedroxyprogesterone acetate male contraceptive regimen. Contraception. 2007 Mar;75(3):218-23. Epub 2007 Jan 16.
PMID:17303493
Reference Type:Results Reference
Citation: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.
PMID:17494097

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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