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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: Completed Phase 3 study of Contraception, sponsored by Duramed Research.

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Duramed Research

23 total trials

What the finished NCT00196352 record still lists

NCT00196352 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 450-participant average among 72 other Contraception trials with a reported enrollment target (29% lower).

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 lists 11 locations in 9 states (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.

Similar trials for Contraception

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00196352's enrollment target sits among peer trials

320 28th of 72 higher than 45 of 72 other Contraception trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00196352, the US trial registry maintained by the National Library of Medicine. NCT00196352 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.