At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 115 enrolled
Drug / intervention
IKH-01 +1 moredrug
Likely dose
IKH-01 0.035mgfrom 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.
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.
In Brief
A Phase 3 clinical trial evaluating IKH-01 and Placebo for Dysmenorrhea. Completed, enrolled 115 participants.
Detailed Summary
The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedSep 3, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.8 years ago
Interventions
IKH-01drug
ethinyl estradiol 0.035mg and norethisterone 1mg
Placebodrug
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg