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NCT00996580 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

A Phase 3 study of Pregnancy Prevention, sponsored by Teva Women's Health.

Completed
Registry status
Phase 3
Development phase
3,597
Enrollment target
20
Study locations

NCT00996580 is a Phase 3 study of Pregnancy Prevention that has completed, run by Teva Women's Health. The registered enrollment target is 3,597 participants, above the 95-participant average among 4 other Pregnancy Prevention trials with a reported enrollment target (3686% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT00996580, a Phase 3 study of Pregnancy Prevention, has completed, sponsored by Teva Women's Health.

COMPLETED
Registry status
Phase 3
Development phase
3,597 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Conditions Studied

Interventions

  • DRUG DR-103

Study Locations (20)

California

  • Teva Women's Health Research Investigational Site - Anaheim
  • Teva Women's Health Research Investigational Site - Irvine
  • Teva Women's Health Research Investigational Site - Los Angeles
  • Teva Women's Health Research Investigational Site - National City
  • Teva Women's Health Research Investigational Site - San Diego
  • Teva Women's Health Research Investigational Site - San Diego
  • Teva Women's Health Research Investigational Site - San Diego
  • Teva Women's Health Research Investigational Site - San Francisco
  • Teva Women's Health Research Investigational Site - Torrance

Arizona

  • Teva Women's Health Research Investigational Site - Phoenix
  • Teva Women's Health Research Investigational Site - Phoenix
  • Teva Women's Health Research Investigational Site - Tucson

Florida

  • Teva Women's Health Research Investigational Site - Clearwater
  • Teva Women's Health Research Investigational Site - Jacksonville
  • Teva Women's Health Research Investigational Site - Leesburg

Colorado

  • Teva Women's Health Research Investigational Site - Colorado Springs
  • Teva Women's Health Research Investigational Site - Pueblo

Alabama

  • Teva Women's Health Research Investigational Site - Montgomery

Arkansas

  • Teva Women's Health Research Investigational Site - Little Rock

District of Columbia

  • Teva Women's Health Research Investigational Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 3,597 participants
Start Date 2009-10
Est. Completion 2011-09
Phase Phase 3

Sponsor

Teva Women's Health

2 total trials

What the Registry Record Tells You About NCT00996580

The ClinicalTrials.gov registry entry for NCT00996580 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,597 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 95-participant average among 4 other Pregnancy Prevention trials with a reported enrollment target (3686% higher). The listed sponsor is Teva Women's Health, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pregnancy Prevention appearing as the primary indexed condition, and to 1 intervention - of which DR-103 is the first listed.

NCT00996580 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT00996580 about?

NCT00996580 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy". This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

What is the current status of trial NCT00996580?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,597 participants. The study started on 2009-10. Estimated completion is 2011-09.

What conditions does trial NCT00996580 study?

This clinical trial studies the following conditions: Pregnancy Prevention.

What interventions are being tested in trial NCT00996580?

The interventions under investigation include: DR-103 (DRUG).

Who is sponsoring clinical trial NCT00996580?

This trial is sponsored by Teva Women's Health, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00996580 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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

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.