Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea

Trial statusNot yet recruiting
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 DEH113 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 < 4 months prior to study selection;

Trial design

Treatments tested in this trial

  • DEH113
  • Placebo Comparator

Treatment groups

78 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators