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NCT00196352 · ClinicalTrials.gov registry record · Phase 3

A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.

A Phase 3 study of Contraception, sponsored by Duramed Research.

Completed
Registry status
Phase 3
Development phase
320
Enrollment target
11
Study locations

NCT00196352 is a Phase 3 study of Contraception that has completed, run by Duramed Research. The registered enrollment target is 320 participants, below the 450-participant average among 72 other Contraception trials with a reported enrollment target (29% lower). The trial reports 11 study locations across 9 states.

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The verdict

NCT00196352, a Phase 3 study of Contraception, has completed, sponsored by Duramed Research.

COMPLETED
Registry status
Phase 3
Development phase
320 participants
Enrollment target
11
Study locations

Study Summary

This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

Conditions Studied

Interventions

  • DRUG Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets

Study Locations (11)

North Carolina

  • Duramed Investigational Site - Charlotte
  • Duramed Investigational Site - Winston-Salem

Virginia

  • Duramed Investigational Site - Arlington
  • Duramed Investigational Site - Norfolk

Arizona

  • Duramed Investigational Site - Tucson

District of Columbia

  • Duramed Investigational Site - Washington D.C.

Nebraska

  • Duramed Investigational Site - Lincoln

New York

  • Duramed Investigational Site - Rochester

Ohio

  • Duramed Investigational Site - Columbus

Oklahoma

  • Duramed Investigational Site - Oklahoma City

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2003-05
Est. Completion 2006-11
Phase Phase 3

Sponsor

Duramed Research

23 total trials

What the Registry Record Tells You About NCT00196352

The ClinicalTrials.gov registry entry for NCT00196352 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 450-participant average among 72 other Contraception trials with a reported enrollment target (29% lower). The listed sponsor is Duramed Research, which has 23 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 Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets is the first listed.

NCT00196352 reports 11 study locations spanning 9 distinct geographic areas - top geographies include North Carolina, Virginia, Arizona.

Frequently Asked Questions

What is clinical trial NCT00196352 about?

NCT00196352 is a clinical study titled "A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.". This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

What is the current status of trial NCT00196352?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2003-05. Estimated completion is 2006-11.

What conditions does trial NCT00196352 study?

This clinical trial studies the following conditions: Contraception.

What interventions are being tested in trial NCT00196352?

The interventions under investigation include: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets (DRUG).

Who is sponsoring clinical trial NCT00196352?

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

Where is trial NCT00196352 being conducted?

This trial has 11 study locations across Arizona, District of Columbia, Nebraska, New York, North Carolina. 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.