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NCT00391807 · ClinicalTrials.gov registry record · Phase 3

Study of Safety and Efficacy of an Oral Contraceptive

A Phase 3 study, sponsored by Warner Chilcott.

Completed
Registry status
Phase 3
Development phase
1,683
Enrollment target

NCT00391807: Completed Phase 3 study, sponsored by Warner Chilcott.

NCT00391807 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 1,683 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00391807, a Phase 3 study, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 3
Development phase
1,683 participants
Enrollment target

Study Summary

This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

Interventions

  • DRUG Norethindrone acetate/ethinyl estradiol

Trial Details

FieldValue
Enrollment Target 1,683 participants
Start Date 2006-11
Est. Completion 2008-09
Phase Phase 3
Warner Chilcott

53 total trials

What the finished NCT00391807 record still lists

NCT00391807 is an interventional study that assigns participants to a tested intervention. Its 1,683 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 (118% higher).

The record links to 0 conditions, and to 1 intervention - of which Norethindrone acetate/ethinyl estradiol is the first listed.

NCT00391807 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00391807 about?

NCT00391807 is a clinical study titled "Study of Safety and Efficacy of an Oral Contraceptive". This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

What is the current status of trial NCT00391807?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,683 participants. The study started on 2006-11. Estimated completion is 2008-09.

What interventions are being tested in trial NCT00391807?

The interventions under investigation include: Norethindrone acetate/ethinyl estradiol (DRUG).

Who is sponsoring clinical trial NCT00391807?

This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00391807's enrollment target sits among peer trials

1,683 134th of 2000 higher than 1,866 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 NCT00391807, the US trial registry maintained by the National Library of Medicine. NCT00391807 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.