Actively Recruiting
A National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Crossover Study to Assess the Efficacy and Safety of CDE100 in Treating Menstrual Cramp Pain in Primary Dysmenorrhea
Led by EMS · Updated on 2025-12-08
238
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of CDE100 for treating menstrual cramp pain associated with primary dysmenorrhea in females aged 16 to 35 years. This phase III randomized, double-blind, double-dummy crossover study compares CDE100 to Buscopan4 Composto in managing moderate to severe menstrual cramps. The study aims to better understand pain relief over several hours post-dose and monitor safety over an extended period. Participants receive either CDE100 with a placebo of Buscopan4 Composto or Buscopan4 Composto with a placebo of CDE100. They take one pill of the assigned medication as needed for pain, up to three times daily. The crossover design means participants will switch treatments during the study, allowing comparison within the same individual. Treatment periods are closely monitored for pain relief and medication use. During the study, participants will have their pain relief evaluated using specific measures like the Sum of Total Pain Relief (TOTPAR) over 4 and 8 hours and the Sum of Pain Intensity Difference (SPID). Researchers will also track use of rescue medication, patients' overall impression of change, and safety for up to 175 days. Participants can expect regular assessments and data collection on their menstrual pain and response to treatments throughout the study period.
CONDITIONS
Brief 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...
- 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, occurring every 21 to 35 days
- Clinical history compatible with the diagnosis of primary dysmenorrhea
- Self-reported history of at least 4 painful cycles with moderate or severe menstrual cramps in the six months prior to selection for the study
You will not qualify if you...
- Diagnosis of secondary dysmenorrhea
- History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for menstrual cramps
- Onset of primary dysmenorrhea after starting oral contraceptives
- Use of oral contraceptives for less than 3 months prior to study selection
- Use of intrauterine device, hormonal implants, or contraceptive injections in the last six months
- Diagnosis or history indicating endometriosis, pelvic inflammatory disease, adenomyosis, uterine fibroma, cystic ovary, or pelvic varicocele
- History of recurrent pelvic or lower abdominal pain outside menstrual periods
- Known allergy or hypersensitivity to study drug components
- History of hypersensitivity reactions to aspirin or other NSAIDs
- History or diagnosis of peptic or hemorrhagic ulcer
- History of gastrointestinal bleeding or perforation related to NSAIDs
- Compromised bone marrow function or hematopoietic diseases
- Diagnosis of acute intermittent hepatic porphyria
- Diagnosis of congenital glucose-6-phosphate dehydrogenase deficiency (G6PD)
- Diagnosis of untreated angle-closure glaucoma
- Mechanical stenosis in the gastrointestinal tract
- Diagnosis of megacolon or paralytic/obstructive ileus
- Diagnosis of myasthenia gravis
- Treatment with psychoactive drugs in the 30 days prior to selection
- History of alcohol or illicit drug use disorder in the last two years
- Current cancer or cancer treatment in the last five years
- Presence of any serious illness deemed unsafe by the investigator
- Clinical or laboratory findings posing risk to participation or uncontrolled chronic disease
- Pregnant, nursing, or planning pregnancy
- Disagreement with effective barrier contraceptive use unless stable oral contraceptive use or surgical sterility
- Participation in another clinical trial in the last 12 months unless judged beneficial
- Any condition making the patient unfit to participate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 175 days
Participants receive either CDE100 association or Buscopan® Composto association to treat menstrual cramp pain, taking pills up to three times a day if pain occurs. The study uses a crossover design where participants receive both treatments in different periods.
Visits scheduled around treatment cycles depending on menstrual periods
Trial Site Locations
Total: 1 location
1
EMS
Hortolândia, São Paulo, Brazil
Actively Recruiting
Research Team
A
Alexandra F.D. Alves, MSc
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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