Actively Recruiting
Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea
Led by EMS · Updated on 2025-12-08
238
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged between 16 and 35 years old, inclusive
- History of regular menstrual cycles occurring every 21 to 35 days
- Clinical history compatible with primary dysmenorrhea diagnosis
- Self-reported history of 4 or more painful cycles with moderate or severe menstrual cramps in the last 6 months
- Patient has given written informed consent before joining the study
You will not qualify if you...
- Diagnosis of secondary dysmenorrhea
- History of non-response to NSAID treatment for menstrual cramps
- Primary dysmenorrhea starting after beginning oral contraceptives
- Use of oral contraceptives for less than 3 months before study selection
- Use of IUD, hormonal implants, or contraceptive injections in the last 6 months
- Diagnosis or history suggesting endometriosis, pelvic inflammatory disease, adenomyosis, uterine fibroma, cystic ovary, or pelvic varicocele
- Recurrent pelvic or lower abdominal pain outside menstruation
- Allergy or hypersensitivity to study drug components or NSAIDs
- History of peptic or hemorrhagic ulcers, gastrointestinal bleeding, or perforation related to NSAIDs
- Compromised bone marrow or hematopoietic diseases
- Acute intermittent hepatic porphyria
- Glucose-6-phosphate dehydrogenase deficiency
- Untreated angle-closure glaucoma
- Mechanical stenosis in the gastrointestinal tract
- Diagnosis of megacolon, paralytic or obstructive ileus
- Diagnosis of myasthenia gravis
- Treatment with psychoactive drugs in the 30 days before selection
- History of alcohol or drug use disorder in the last 2 years
- Current cancer or cancer treatment in the last 5 years
- Any serious illness or uncontrolled chronic disease judged by investigator
- Pregnant, nursing, or planning pregnancy
- Disagreement with effective barrier contraception use or unstable contraceptive methods
- Participation in another clinical trial in the last 12 months unless benefiting
- Any condition making the patient unfit to participate as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
EMS
Hortolândia, São Paulo, Brazil
Actively Recruiting
Research Team
A
Alexandra F.D. Alves, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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