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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: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT00927095 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 67 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal,
Interventions
- DRUG placebo
- DRUG Continuous OC (EE/DROS)
- DRUG Intermittent OC (EE/DROS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2008-07 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
What the finished NCT00927095 record still lists
NCT00927095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00927095 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00927095's enrollment target sits among peer trials
67 1083rd of 2000 higher than 918 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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