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.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
EMS
RECRUITING
Hortolândia
Contact Information
Primary
Alexandra F.D. Alves, MSc
pesquisa.clinica@ncfarma.com.br
+551938878917
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 238
Treatments
Experimental: Experimental
CDE100 The patient must take 1 pill of CDE100 association and placebo of Buscopan® Composto association, if pain, until three times a day.
Active_comparator: Control
Buscopan® Composto association.~The patient must take 1 pill of Buscopan® Composto association and placebo of CDE100 association, if pain, until three times a day.
Related Therapeutic Areas
Sponsors
Leads: EMS