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COMPLETED Phase 3

Study of Safety and Efficacy of an Oral Contraceptive

NCT00477633 · View on ClinicalTrials.gov ↗

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

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00477633

The ClinicalTrials.gov registry entry for NCT00477633 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00477633 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00477633?

The interventions under investigation include: Norethindrone/ethinyl estradiol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00477633?

This trial is sponsored by Warner Chilcott, which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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