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Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring

StatusCompleted
PhasePhase 3
Started
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Record History

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  1. Results first posted: Jan 23, 2026
    • Primary endpoints: 1 to 3
    • Enrollment target: 1143 to 1200
    • Secondary endpoints: 1 to 4
    v8
  2. Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to Premier Research
    • Study completion date: Sep 2009 to Sep 2011
    • Study description shortened, about 10 words
    • Collaborators: 1 to 2
    v7
  3. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 1200 to confirmed 1143
    • Study completion date changed from estimate of Jun 2009 to Sep 2009
    • Study arms: 0 to 1
    v6
  4. Trial status: Recruiting to Active, Not Recruitingv5 Show 5 more changesShow less
    • Primary completion date: Jan 2009
    • Study completion date: Jun 2009
    • Interventions: 150 mg of NestoroneÒ and 15 mg of ethinyl estradiol (150/15 NES/EE CVR) (Drug) to 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR) (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 15 of 15 sites
  5. Site details revised at 6 of 15 sitesv4
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  1. Study sites: 12 to 15v3
  2. Site contacts updated at 2 of 12 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00455156
Lead Sponsor Premier Research
Collaborators: Population Council, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Contraception
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov