Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • CDE100 association

    Drug

    Experimental drug.

  • Buscopan® Composto association

    Drug

    Active comparator.

Treatment groups

238 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sum of Total Pain Relief (TOTPAR) over 0-4 hours post-dose.

Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).

Time frame
4 hours post-dose.

Secondary outcomes

1

Sum of Total Pain Relief (TOTPAR) over 0-8 hours post-dose.

Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-8 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).

Time frame
8 hours post-dose.
2

Sum of Pain Intensity Difference (SPID) over 4 hours post-dose.

Sum of Pain Intensity Difference (SPID) over 4 hours post-dose. The pain intensity will be assessed using a Categorical 4-point scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain).

Time frame
4 hours post-dose.
3

Sum of Pain Intensity Difference (SPID) over 8 hours post-dose.

Sum of Pain Intensity Difference (SPID) over 8 hours post-dose. The pain intensity will be assessed using a Categorical 4-point scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain).

Time frame
8 hours post-dose.
4

Time to first intake of rescue medication.

Time between the first dose intake and the administration of a rescue medication.

Time frame
Up to 8 hours post-dose.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov
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