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NCT00263341 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone® and Ethinyl Estradiol

A Phase 3 study, sponsored by Population Council.

Completed
Registry status
Phase 3
Development phase
1,135
Enrollment target

NCT00263341: Completed Phase 3 study, sponsored by Population Council.

NCT00263341 is a Phase 3 study that has completed, run by Population Council. The registered enrollment target is 1,135 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00263341, a Phase 3 study, has completed, sponsored by Population Council.

COMPLETED
Registry status
Phase 3
Development phase
1,135 participants
Enrollment target

Study Summary

The purpose of this 1-year study is to evaluate the efficacy and safety of a new contraceptive vaginal ring (CVR) delivering low doses of Nestorone (NES), a new, nonandrogenic progestin, and ethinyl estradiol (EE), an estrogen used in oral contraceptives. The CVR, which is made of silicone rubber, is designed to be used for 1 year (13 menstrual cycles) before replacement is required.

Primary Outcome

Primary endpoint: The Pearl Index for women 35 years of age derived from using all cycles for which back up contraception is not used will be the primary efficacy endpoint. This index will be calculated for the women participating in Protocol 300 B and will then be pooled with data from women 35 years who participate in 300 A (CCN006).

Interventions

  • COMBINATION_PRODUCT NES/EE CVR

Trial Details

FieldValue
Enrollment Target 1,135 participants
Start Date 2005-12
Est. Completion 2014-08
Phase Phase 3
Population Council

11 total trials

What the finished NCT00263341 record still lists

NCT00263341 is an interventional study that assigns participants to a tested intervention. Its 1,135 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher).

The record links to 0 conditions, and to 1 intervention - of which NES/EE CVR is the first listed.

NCT00263341 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00263341 about?

NCT00263341 is a clinical study titled "Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone® and Ethinyl Estradiol". The purpose of this 1-year study is to evaluate the efficacy and safety of a new contraceptive vaginal ring (CVR) delivering low doses of Nestorone (NES), a new, nonandrogenic progestin, and ethinyl estradiol (EE), an estrogen used in oral contraceptives. The CVR, which is made of silicone rubber, i...

What is the current status of trial NCT00263341?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,135 participants. The study started on 2005-12. Estimated completion is 2014-08.

What interventions are being tested in trial NCT00263341?

The interventions under investigation include: NES/EE CVR (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT00263341?

This trial is sponsored by Population Council, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00263341's enrollment target sits among peer trials

1,135 243rd of 2000 higher than 1,757 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00263341, the US trial registry maintained by the National Library of Medicine. NCT00263341 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.