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NCT00477633 · ClinicalTrials.gov registry record · Phase 3

Study of Safety and Efficacy of an Oral Contraceptive

A Phase 3 study of Contraception, sponsored by Warner Chilcott.

Completed
Registry status
Phase 3
Development phase
1,700
Enrollment target
20
Study locations

NCT00477633 is a Phase 3 study of Contraception that has completed, run by Warner Chilcott. The registered enrollment target is 1,700 participants, above the 431-participant average among 72 other Contraception trials with a reported enrollment target (294% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT00477633, a Phase 3 study of Contraception, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 3
Development phase
1,700 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Interventions

  • DRUG Norethindrone/ethinyl estradiol

Study Locations (20)

Florida

  • Warner Chilcott Investigational Site - Boynton Beach
  • Warner Chilcott Investigational Site - Brooksville
  • Warner Chilcott Investigational Site - Clearwater
  • Warner Chilcott Investigational Site - Gainesville
  • Warner Chilcott Investigational Site - Jacksonville
  • Warner Chilcott Investigational Site - Leesburg
  • Warner Chilcott Investigational Site - Miami
  • Warner Chilcott Investigational Site - Miami

Arizona

  • Warner Chilcott Investigational Site - Chandler
  • Warner Chilcott Investigational Site - Phoenix
  • Warner Chilcott Investigational Site - Phoenix
  • Warner Chilcott Investigational Site - Phoenix
  • Warner Chilcott Investigational Site - Tempe
  • Warner Chilcott Investigational Site - Tucson

California

  • Warner Chilcott Investigational Site - San Diego
  • Warner Chilcott Investigational Site - San Diego
  • Warner Chilcott Investigational Site - Vista

Colorado

  • Warner Chilcott Investigational Site - Castle Rock
  • Warner Chilcott Investigational Site - Denver
  • Warner Chilcott Investigational Site - Lakewood

Trial Details

FieldValue
Enrollment Target 1,700 participants
Start Date 2007-06
Est. Completion 2009-02
Phase Phase 3

Sponsor

Warner Chilcott

53 total trials

What the Registry Record Tells You About NCT00477633

The ClinicalTrials.gov registry entry for NCT00477633 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 431-participant average among 72 other Contraception trials with a reported enrollment target (294% higher). The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Norethindrone/ethinyl estradiol is the first listed.

NCT00477633 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT00477633 about?

NCT00477633 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 NCT00477633?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,700 participants. The study started on 2007-06. Estimated completion is 2009-02.

What conditions does trial NCT00477633 study?

This clinical trial studies the following conditions: Contraception.

What interventions are being tested in trial NCT00477633?

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

Who is sponsoring clinical trial NCT00477633?

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

Where is trial NCT00477633 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.