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NCT00927095 · ClinicalTrials.gov registry record · Phase 4

Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)

A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 4
Development phase
67
Enrollment target

NCT00927095 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 67 participants.

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The verdict

NCT00927095, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 4
Development phase
67 participants
Enrollment target

Study Summary

The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously (every day for three months) with the same low dose oral contraceptive given in an interrupted regimen (one week of inactive placebo pills each month) and with continuous placebo (inactive placebo given every day for three months). The primary hypothesis is that continuous OC will be significantly more effective in reducing premenstrual symptoms compared with either the interrupted OC or continuous placebo.

Interventions

  • DRUG placebo
  • DRUG Continuous OC (EE/DROS)
  • DRUG Intermittent OC (EE/DROS)

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2008-07
Est. Completion 2014-07
Phase Phase 4

What the Registry Record Tells You About NCT00927095

The ClinicalTrials.gov registry entry for NCT00927095 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00927095 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00927095 about?

NCT00927095 is a clinical study titled "Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)". The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously (every day for three months) with the same low dose oral contraceptive given in an interrupted regimen (one week of inactive placebo pills each month) and with continuous placebo (inactive placebo given eve...

What is the current status of trial NCT00927095?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 67 participants. The study started on 2008-07. Estimated completion is 2014-07.

What interventions are being tested in trial NCT00927095?

The interventions under investigation include: placebo (DRUG), Continuous OC (EE/DROS) (DRUG), Intermittent OC (EE/DROS) (DRUG).

Who is sponsoring clinical trial NCT00927095?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.