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Hormone Therapy
Regimen 1: Continuous Usage for Birth Control
Phase 2
Waitlist Available
Research Sponsored by Health Decisions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This will be a multi-site, open-label, randomized clinical trial. The investigators will randomize 300 eligible participants in a 1:1 ratio to two different treatment regimens that are to be followed when using a contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR).
Eligible Conditions
- Healthy Women
- Birth Control
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Group I: Regimen 2: Cyclical UsageExperimental Treatment1 Intervention
Contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR) worn for 91 days, but is removed for 2 days each month (days 29-30, 59-60, and 90-91).
Group II: Regimen 1: Continuous UsageExperimental Treatment1 Intervention
Contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR) worn continuously for 91 days.
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Who is running the clinical trial?
Population CouncilOTHER
51 Previous Clinical Trials
62,675 Total Patients Enrolled
Health DecisionsLead Sponsor
30 Previous Clinical Trials
13,597 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,534 Total Patients Enrolled
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