CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 420 enrolled
Drug / intervention
DRSP 3 mg/EE 20 µg (13 cycles) +1 moredrug
Likely dose
DRSP 3 mg/EE 20 µg (13 cycles)from 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/NCT00461305
NCT00461305Phase 3Completed
CompareCT.gov

A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)

Bayer·interventional·Posted Apr 18, 2007·Updated Jan 24, 2013

In Brief

A Phase 3 clinical trial evaluating DRSP 3 mg/EE 20 µg (13 cycles) and DRSP 3 mg/EE 30 µg (6 cycles) for Dysmenorrhea. Completed, enrolled 420 participants across 26 sites.

Detailed Summary

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJan 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.2 years ago

Interventions

DRSP 3 mg/EE 20 µg (13 cycles)drug

1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)

DRSP 3 mg/EE 30 µg (6 cycles)drug

1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)