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NuvaRing Cycle Control and Acceptability in Indian Women
NCT01490190Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2011
- Primary completion
- Dec 2012
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Conditions
- contraception
01
Overview
Phase 4, open-label, single-arm trial of etonogestrel + ethinyl estradiol in contraception, sponsored by Organon & Co. Primary endpoints: Number of Participants With Regular Menstrual Cycles at 84 days, Average Number of Bleeding Days Per Cycle at 84 days and 11 more. Started Dec 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
NuvaRing
Ethinylestradiol + Etonogestrel Vaginal Ring used for 3 cycles
03
Who it enrols
Women at risk of pregnancy and seeking contraception, excluding those with history of thrombosis, migraine with focal neurological symptoms, diabetes with vascular involvement, severe hepatic disease, or hormone-sensitive malignancies.
04
Endpoints
Primary
Number of Participants With Regular Menstrual Cycles
Average Number of Bleeding Days Per Cycle
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
Number of Participants With Intermenstrual Bleeding/Spotting
Number of Spotting Days Per Cycle
Secondary
Number of Pregnancies Due to Contraceptive Method Failure During the Study
Number of Participants Who Reported at Least One Adverse Event During the Study
Number of Participants Who Reported a Serious Adverse Event During the Study
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