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Male Contraception Study (DMAU IM CCN015)

Male Contraception Study (DMAU IM CCN015)

The purpose of this study is to test how safe DMAU is and how well it is tolerated when given to men as an injection. This study will also look at how the medication is metabolized in the body (how fast it is absorbed into the bloodstream and how quickly it is cleared out of the body) and how it affects the hormones controlling the function of the testes.

DMAU has been given to a very small number of men before. The long-term goal of studying this medication is to use it as a male contraceptive (birth control).

The study will take approximately 5-7 months to complete. During this time you will have to come to the clinic for approximately 12-16 visits; the exact number of visits will depend on how quickly your sperm count returns to normal after receiving the injection.

Participant Eligibility

Men who join the study should be healthy and between the ages of 18-50 years and will be required to use an effective method of contraception if they have a female partner (i.e. at a minimum, condom for the male subject and an effective contraceptive for the female partner).

GENERAL REQUIREMENTS FOR ENTERING THE STUDY:

  • Male, age 18-50 years
  • Be in good health with no current or chronic diseases
  • No current or previous excessive alcohol use, illicit drug, or anabolic steroid abuse
  • Fast for at least 8 hours (nothing to eat) during study prior to blood draws
  • Able to provide semen samples
  • No participation in a research study within 30 days of screening visit

Contact

Kathy Winter
(206) 616-0484

Additional Study Details

Full Study Title
Injectable DMAU for Male Contraception: Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Single IM or SC DMAU Injection Dose Escalation Study in Healthy Male Volunteers

Study ID: 52645-A
Start Date: 10/19/2016
End Date: 09/04/2020

Investigator(s)
Stephanie Page, MD, PhD; William Bremner, MD, PhD; John Amory, MD, MPH; Sherry Wu, MD

Accepts Healthy Volunteers?
Yes

Study Site(s)

University of Washington

1959 NE Pacific Street Health Science Bldg, Room C209
Seattle, Washington 98195



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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