Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-35
SponsorEMS

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators