Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea
ConditionPrimary Dysmenorrhea
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age16-35
SponsorEMS
About this trial
The purpose of this study if to evaluate the efficacy and safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
Eligibility criteria
Qualifiers
Patient has given written informed consent to participate in the study prior to admission to the study;
Female patients aged between 16 and 35 years old, inclusive;
History of regular menstrual cycles, occuring between every 21 to 35 days;
Clinical history compatible with the diagnosis of primary dysmenorrhea;
Disqualifiers
Diagnosis of secondary dysmenorrhea;
History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps;
Onset of primary dysmenorrhea after starting to use oral contraceptives;
Use of oral contraceptives for < 3 months prior to study selection;
Trial design
Treatments tested in this trial
- CDE100 association
- Buscopan® Composto association
Treatment groups
238 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov