drugset / Trial / NCT03120728

Application for the Etonogestrel/Ethinyl Estradiol Ring

NCT03120728 ↗

Phase 4 Unknown 36 enrolled University of Southern California
Non-randomizedParallel-groupOpen-labelPrevention

Summary

This study is enrolling healthy women ages 18-39yo who are not pregnant or breastfeeding, and are not using hormonal birth control. Initial screening visit will include a blood draw to assess if the participant has recently ovulated. If hormone test indicates ovulation occurred, participant will start the study 8 days after the start of their next menstrual period. On this study visit, vaginal ultrasound will be performed to look the ovaries for follicles. Vaginal ultrasound is then performed approximately every 2 days until the dominant follicle has grown into the size group assigned. When this occurs the participant will place the NuvaRing®, inside the vagina and blood will be drawn for hormone levels. Participant will then return daily the next 5 days (total of 6 daily visits) for vaginal ultrasound and blood draw to assess for signs of ovulation. After the 7th day the ring is in the vagina, the participant will remove the ring from her vagina at home. After removal, there will be twice weekly clinic visits for ultrasound and blood draw until menstrual bleeding occurs. At this point, participation in the study is complete. Participants are compensated for their time.

Timeline

Start
2017-07-10
Primary completion
2018-06-30
Completion
2018-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Etonogestrel/ethinyl estradiol Unknown — Other

Indications

No indication recorded.