A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Comb… (NCT02451826) | Clinical Trial Compass
UnknownPhase 1/2
A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women
Dominican Republic19 participantsStarted 2015-05
Plain-language summary
The purpose of this study is to determine the effect of a contraceptive vaginal ring on inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women.
Who can participate
Age range21 Years – 35 Years
SexFEMALE
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Inclusion Criteria:
* Not at risk for pregnancy based on one of the following: a. subject has undergone sterilization; b. subject is monogamous and her male partner has undergone sterilization
* Have regular menstrual cycles of 25-35 days duration
* Have an intact uterus and both ovaries
* Will be able to comply with the protocol
* Capable of giving informed consent
Exclusion Criteria:
* Women participating in another clinical trial
* Women not living in the catchment area of the clinic
* Known hypersensitivity to progestins or antiprogestins
* Known hypersensitivity to silicone rubber
* Any chronic disease
* All contraindications to oral contraceptive use, including: a. Thrombophlebitis or thromboembolic disorders; b. Past history of deep vein thrombophlebitis or thromboembolic disorders; c. Past or current cerebrovascular or coronary artery disease; d. Migraine with focal aura; e. Known or suspected carcinoma of the breast; f. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; g. Undiagnosed abnormal genital bleeding; h. Cholestatic jaundice of pregnancy or jaundice with prior pill use; i. Hepatic adenomas or carcinomas; j. Known or suspected pregnancy
* Desire to get pregnant during the study (through the use of reproductive technology for sterilized women or vasectomy reversal for sterilized partners)
* Breastfeeding
* Undiagnosed vaginal discharge or vaginal lesions or abnormalities
* Women with a current abnormal Pap: In accordance…
What they're measuring
1
Pharmacodynamic efficacy as measured by the effects of a vaginal ring delivering Ulipristal acetate consistently combined with levonorgestrel administration on the endometrium