CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 67 enrolled
Drug / intervention
Continuous OC (EE/DROS) +2 moredrug
Likely dose
Continuous OC (EE/DROS) 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00927095
NCT00927095Phase 4Completed
CompareCT.gov

Continuous OC Treatment in PMDD: Steroid Hormone Mechanisms

University of North Carolina, Chapel Hill·interventional·Posted Jun 24, 2009·Updated Aug 24, 2016

In Brief

A Phase 4 clinical trial evaluating Continuous OC (EE/DROS), Intermittent OC (EE/DROS), and 1 other intervention for Premenstrual Dysphoric Disorder. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremenstrual Dysphoric Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 24, 2009
Enrollment StartJul 1, 2008
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 17.0 years ago

Interventions

Continuous OC (EE/DROS)drug

Continuous EE(20ug)+DROS(3mg) daily for 3 months

Intermittent OC (EE/DROS)drug

Intermittent EE(20ug)+DROS(3mg) daily for 21 days each month

placebodrug

daily placebo