RecruitingPhase 3NCT05640232

Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea

A National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III, Crossover Study to Assess the Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.


Sponsor

EMS

Enrollment

238 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 16 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Buscopan® Composto association and a drug called CDE100 association for people with primary dysmenorrhea. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 16 Years to 35 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCDE100 association

Experimental drug.

DRUGBuscopan® Composto association

Active comparator.


Locations(1)

EMS

Hortolândia, São Paulo, Brazil

View Full Details on ClinicalTrials.gov

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NCT05640232


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