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NCT00196326 · ClinicalTrials.gov registry record · Phase 3

Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

A Phase 3 study, sponsored by Duramed Research.

Completed
Registry status
Phase 3
Development phase
2,235
Enrollment target

NCT00196326 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 2,235 participants.

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The verdict

NCT00196326, a Phase 3 study, has completed, sponsored by Duramed Research.

COMPLETED
Registry status
Phase 3
Development phase
2,235 participants
Enrollment target

Study Summary

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Interventions

  • DRUG DR-1011

Trial Details

FieldValue
Enrollment Target 2,235 participants
Start Date 2005-06
Est. Completion 2007-06
Phase Phase 3

Sponsor

Duramed Research

23 total trials

What the Registry Record Tells You About NCT00196326

The ClinicalTrials.gov registry entry for NCT00196326 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,235 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which DR-1011 is the first listed.

NCT00196326 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00196326 about?

NCT00196326 is a clinical study titled "Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive". This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. 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 NCT00196326?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,235 participants. The study started on 2005-06. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00196326?

The interventions under investigation include: DR-1011 (DRUG).

Who is sponsoring clinical trial NCT00196326?

This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.

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.