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NCT00196365 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

A Phase 3 study, sponsored by Duramed Research.

Completed
Registry status
Phase 3
Development phase
97
Enrollment target

NCT00196365: Completed Phase 3 study, sponsored by Duramed Research.

NCT00196365 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 97 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00196365, a Phase 3 study, has completed, sponsored by Duramed Research.

COMPLETED
Registry status
Phase 3
Development phase
97 participants
Enrollment target

Study Summary

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

Interventions

  • DRUG levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
  • DRUG levonorgestrel/EE 0.15/0.03 mg tablets and placebo

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2005-01
Est. Completion 2007-07
Phase Phase 3
Duramed Research

23 total trials

What the finished NCT00196365 record still lists

NCT00196365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets is the first listed.

NCT00196365 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00196365 about?

NCT00196365 is a clinical study titled "A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain". This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9...

What is the current status of trial NCT00196365?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2005-01. Estimated completion is 2007-07.

What interventions are being tested in trial NCT00196365?

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

Who is sponsoring clinical trial NCT00196365?

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

How this trial's enrollment target compares

Where NCT00196365's enrollment target sits among peer trials

97 1718th of 2000 higher than 283 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00196365, the US trial registry maintained by the National Library of Medicine. NCT00196365 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.