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Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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.

NCT05640232•EMS

View on ClinicalTrials.gov

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

Age

16 - 35 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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;
•Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study.

Exclusion Criteria

•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;
•Use of an intrauterine device (IUD), hormonal implants or contraceptive injections in the last six (06) months;
•Previous diagnosis or physical examination findings and/or clinical and/or surgical history that may indicate the presence of endometriosis, pelvic inflammatory disease, adenomyosis, mullerian duct malformation, uterine fibroma, cystic ovary and/or pelvic varicocele;
•History of recurrent pelvic and/or lower abdominal pain outside the menstrual period;
•Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;
•History of hypersensitivity reactions, such as asthma attacks or other types of allergic reactions, to acetylsalicylic acid or other NSAIDs;
•History or diagnosis of peptic/hemorrhagic ulcer;
+17 more criteria

Locations (1)

EMS

Hortolândia, São Paulo, Brazil

Key Dates

Start Date

June 11, 2025

Primary Completion Date

June 28, 2026

Completion Date

January 30, 2027

Last Updated

December 8, 2025

Enrollment

238

ESTIMATED participants

Conditions

Primary Dysmenorrhea

Interventions

CDE100 association

DRUG

Buscopan® Composto association

DRUG

Contacts

Alexandra F.D. Alves, MSc

CONTACT

+551938878917 pesquisa.clinica@ncfarma.com.br

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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