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RecruitMe Clinical Trial

A Phase I study to evaluate the pharmacokinetic and pharmacodynamic profile of intramuscular or subcutaneous injections of levonorgestrel butanoate (LB) for female contraception
Study seeking to evaluate the effectiveness of LB as a possible injection contraception method (females age 18-40)
Sponsor:NICHD
Enrolling:Female Patients Only
Study Length:9 Months
Clinic Visits:36
Age Range:Between 18 and 40 years old
IRB Number:AAAS6691
U.S. Government ID:NCT04143659
Contact: Molly Morgan: 212-305-0947 / mjm2331@cumc.columbia.edu
Additional Study Information:

The study is looking to evaluate levonogestrel butanoate as a possible new long-acting injectable for birth control. Levonogestrel butanoate is a type of hormone called progestin that has a long history of clinical use in a variety of birth control methods (e.g. pills, intrauterine devices, implants) and its efficacy and safety are well recognized. This study is seeking for healthy female volunteers between the ages of 18-40 years of age. Participation time is estimated to last up to 9 months with approximately 36 study visits.The first visit will last about 1 hour and all other visits will typically last about 30-45 minutes with the exception of visit 3 that is expected to last 8-10 hours. Study visits will vary but mostly consist of physical and gynecological exams, transvaginal ultrasounds, urine pregnancy test, and blood draws.

Do You Qualify?
Are you a female between 18 to 40 years of age?YesNo
Do you have regular menstrual cycles?YesNo
Are you sexually active, but not trying to get pregnant?YesNo
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Investigator
Carolyn Westhoff, MD
You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Molly Morgan
Email: mjm2331@cumc.columbia.edu
Phone: 212-305-0947