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COMPLETED Phase 3

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

NCT00996580 · View on ClinicalTrials.gov ↗

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

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00996580

The ClinicalTrials.gov registry entry for NCT00996580 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 3,597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Women's Health, which has 1 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 Pregnancy Prevention appearing as the primary indexed condition, and to 1 intervention — of which DR-103 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: NCT00996580 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Arizona, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00996580?

The interventions under investigation include: DR-103 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00996580?

This trial is sponsored by Teva Women's Health, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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