Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Health Decisions

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Inclusion Criteria

Good general overall health with no chronic medical conditions that result in periodic exacerbations requiring significant medical care.

Age 18-35 years, inclusive, at the enrollment visit. (Note: subjects must be at least 18 years of age to provide consent.)

Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception

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Treatment Details

Interventions

NES-E2 CVR (Hormone Therapy)

Participant Groups

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.