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A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women

NCT01586000 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2025-12-08

Study results available
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Summary

This clinical trial is an experimental research study using a potential new form of birth control. Clinical trials include people who volunteer to take part in a study. Take your time to decide if you want to be part of this experimental research study. If you want to know more about this study first, ask the study doctor or study site staff. The investigators can also give you the study information written for doctors and clinic staff.

Conditions

  • Suppression of Ovulation

Interventions

DRUG

10 µg/day E2 with NES 200® µg/day

10 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

DRUG

20 µg/day E2 with NES 200® µg/day

20 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

DRUG

40 µg/day E2 with NES 200® µg/day

40 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Population Council

    collaborator OTHER

  • Kimberly Myer

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586000 on ClinicalTrials.gov