A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety,Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles
A study for women using contraceptive study drug LF111
Sponsor: Laboratories Leon Farma, S.A.
Enrolling: Male and Female Patients
Study Length: 13 Months
Clinic Visits: 8
IRB Number: AAAO5019
U.S. Govt. ID: NCT02269241
Contact: Claudia Roca: 212-342-2986 / cr479@columbia.edu
Additional Study Information: The purpose of this study is to find out how safe and effective investigational birth control pill, LF111 may be as a contraceptive, how it affects women's menstrual bleeding patterns, and how long LF111 stays in women's bodies. Participants will take the new experimental birth control pill for one year, and will come to the medical center for 8 research visits over 13.5 months.
This study is closed
Investigator
Anne Davis, MD
Do You Qualify?
Are you sexually active and at risk of pregnancy? Yes No
Have you had regular menstrual cycles for the past six months? Yes No
Are you currently pregnant or breastfeeding? Yes No
Do you have a history of infertility? Yes No
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For more information, please contact:
Claudia Roca
cr479@columbia.edu
212-342-2986
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