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Dose Finding Study of Contraceptive Vaginal Ring With Different Estradiol Levels in Combination With Nestorone

NCT02626208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-08-15

No results posted yet for this study

Summary

This clinical trial investigates a new vaginal delivery system made of silicone rubber, containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings that contain a fixed dose of NES and escalating doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR for a larger contraceptive efficacy trial.

Conditions

  • Suppression of Ovulation

Interventions

DEVICE

Nestorone®/Estradiol Contraceptive Vaginal Ring

Three arms of contraceptive vaginal rings contain a fixed dose (200 mcg/day) of Nestorone® and escalating doses (75 µg/d, 100 µg/d, or 200 µg/d /day) of estradiol

Sponsors & Collaborators

  • Population Council

    collaborator OTHER

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

    collaborator NIH

  • Premier Research

    lead OTHER

Principal Investigators

  • Diana Blithe, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT02626208 on ClinicalTrials.gov