At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 280 enrolled
Drug / intervention
high dose KYG0395 +2 moredrug
Likely dose
Not stated in 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 Multi-Center, Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Further Assess the Efficacy, Safety and Dose Response of KYG0395 in the Treatment of Primary Dysmenorrhea
In Brief
A Phase 2 clinical trial evaluating high dose KYG0395, lower dose KYG0395, and 1 other intervention for Primary Dysmenorrhea. Completed, enrolled 280 participants across 23 sites.
Detailed Summary
The purpose of this study is to further assess the efficacy, safety and dose-response of KYG0395 in the treatment of primary dysmenorrhea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Dysmenorrhea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartMay 2012
Primary CompletionJul 2015
TodayJul 2026
First PostedApr 30, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.2 years ago
Interventions
high dose KYG0395drug
3 KYG0395 capsules tid (morning, midday, and evening)
lower dose KYG0395drug
3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
Placebodrug
3 capsules of placebo tid (morning, midday, and evening)