CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,200 enrolled
Drug / intervention
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)drug
Likely dose
150 µg Nestorone and 15 µg ethinyl estradiol delivered via vaginal ring, 21 days in/7 days out schedule for up to 1 yearAI-extracted
Key inclusion· 6
  • ✓Healthy women aged 18 to <40 years seeking combined hormonal contraception
  • ✓Not intending to become pregnant for at least 13 months
  • ✓Intact uterus and both ovaries
  • ✓Prior history of regular menstrual cycles (28 ± 7 days off hormones, or 21–35 days if postpartum/postabortal with ≥1 cycle matching prior pattern)
Key exclusion· 18
  • ✕Known hypersensitivity to estrogens, progestins, or silicone rubber
  • ✕Known or suspected pregnancy
  • ✕History of infertility >1 year in woman or partner, or partner vasectomy, or female tubal ligation
  • ✕Undiagnosed abnormal genital bleeding, vaginal discharge, or vaginal lesions/abnormalities

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00455156
NCT00455156Phase 3Completed
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A Multicenter, Open-label Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of 150µg of Nestorone® and 15µg of Ethinyl Estradiol (150/15 NES/EE CVR)

Premier Research·interventional·Posted Apr 3, 2007·Updated Jan 23, 2026

In Brief

A Phase 3 clinical trial evaluating 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR) for Contraception. Completed, enrolled 1,200 participants across 15 sites.

Detailed Summary

The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
CollaboratorsPopulation Council, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2007
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2009
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.2 years ago

Interventions

150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)drug

150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.