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NCT00117273 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens

A Phase 3 study, sponsored by Duramed Research.

Completed
Registry status
Phase 3
Development phase
36
Enrollment target

NCT00117273 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 36 participants.

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The verdict

NCT00117273, a Phase 3 study, has completed, sponsored by Duramed Research.

COMPLETED
Registry status
Phase 3
Development phase
36 participants
Enrollment target

Study Summary

This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).

Interventions

  • DRUG Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
  • DRUG Seasonique (LNG/EE and EE)
  • DRUG Portia (LNG/EE)

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2005-06
Est. Completion 2006-06
Phase Phase 3

Sponsor

Duramed Research

23 total trials

What the Registry Record Tells You About NCT00117273

The ClinicalTrials.gov registry entry for NCT00117273 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 36 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 3 interventions - of which Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] is the first listed.

NCT00117273 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00117273 about?

NCT00117273 is a clinical study titled "A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens". This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of place...

What is the current status of trial NCT00117273?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2005-06. Estimated completion is 2006-06.

What interventions are being tested in trial NCT00117273?

The interventions under investigation include: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] (DRUG), Seasonique (LNG/EE and EE) (DRUG), Portia (LNG/EE) (DRUG).

Who is sponsoring clinical trial NCT00117273?

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.