Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2004-05-31
2006-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
Testosterone Gel
Testosterone Gel (10 g daily
Depo-Medroxyprogesterone
DMPA (injected into muscle) Day 0 \& month 3
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
Acyline
Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
Testosterone Gel
Testosterone Gel (10 g daily
Depo-Medroxyprogesterone
DMPA (injected into muscle) Day 0 \& month 3
Interventions
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Acyline
Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
Testosterone Gel
Testosterone Gel (10 g daily
Depo-Medroxyprogesterone
DMPA (injected into muscle) Day 0 \& month 3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In good general health
* With normal sperm counts
* Willing to use an acceptable form of contraception
Exclusion Criteria
* 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
18 Years
55 Years
MALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
CONRAD
OTHER
University of Washington
OTHER
Responsible Party
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University of Washington
Principal Investigators
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William J Bremner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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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. doi: 10.1093/humrep/13.5.1225.
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.
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. doi: 10.1210/jcem.86.1.7057.
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. doi: 10.1210/jcem.87.7.8675.
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.
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 Nov;91(11):4374-80. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.
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. doi: 10.1016/j.contraception.2006.11.003. Epub 2007 Jan 16.
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. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.
Other Identifiers
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04-0832-D
Identifier Type: -
Identifier Source: org_study_id