At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 249 enrolled
Drug / intervention
SH T04740B +3 moredrug
Likely dose
SH T04740B 1mgfrom 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.
A Multicenter, Double-blind, Randomized, Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.
In Brief
A Phase 3 clinical trial evaluating SH T04740B, SH T00186DF, and 2 other interventions for Dysmenorrhea. Completed, enrolled 249 participants across 12 sites.
Detailed Summary
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedAug 2007
Primary CompletionJan 2009
TodayJul 2026
First PostedAug 6, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.9 years ago
Interventions
SH T04740Bdrug
Drospirenone 1mg/EE 20µg (ß-CDC)
SH T00186DFdrug
Drospirenone 3 mg/EE 20µg (ß-CDC)
SH T04740Fdrug
Drospirenone 2 mg/EE 20µg (ß-CDC)
Placebodrug
Placebo