About this trial
This study aims to evaluate the preliminary efficacy and safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated with Primary Dysmenorrhea.
Eligibility criteria
Qualifiers
Patient has given written informed consent to participate in the study before admission to the study;
Female patients aged between 16 and 35 years old, inclusive;
History of regular menstrual cycles, occurring 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
- DEH113
- Placebo