The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on: 1. follicular function and inhibition of ovulation 2. the endometrium 3. bleeding patterns; and also to assess safety including effects on the endometrium
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914
Oregon Health & Science University
Portland, Oregon, United States
Instituto Chileno de Medicina Reproductiva
Santiago, Chile
Profamilia
Santo Domingo, Dominican Republic
The primary efficacy variable will be ovulation suppression measured by progesterone serum levels.
Time frame: All women will use the assigned CVR for 6 months
Regular follow-up of follicle diameter will be made with USS to determine the timing of ovulation or, in the absence of ovulation, the fate of the dominant follicle.
Time frame: All women will use the assigned CVR for 6 months
Clinical safety will be evaluated and the effects on the endometrium will be measured.
Time frame: All women will use the assigned CVR for 6 months
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