What is CDE100 studying for primary dysmenorrhea?

CDE100 is being studied as a treatment for menstrual cramp pain in primary dysmenorrhea. This trial evaluates how well it relieves pain compared to another medication, Buscopan4 Composto, and monitors safety. The sponsor EMS is conducting this research to find better options for managing menstrual cramps.

Who may be eligible for this primary dysmenorrhea clinical trial?

Females aged 16 to 35 with regular menstrual cycles and a history of moderate to severe menstrual cramps are eligible. Exclusions include secondary dysmenorrhea, recent use of certain contraceptives, and some medical conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this primary dysmenorrhea clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their transportation needs.

Actively Recruiting

Phase 3

Age: 16Years - 35Years

FEMALE

ID05640232

Study of CDE100 for Treating Menstrual Cramp Pain in Women With Primary Dysmenorrhea Aged 16 to 35

Led by EMS · Updated on 2025-12-08

238

Participants Needed

Research Sites

30 weeks

Total Duration

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

Age: 16Years - 35Years

FEMALE

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

Research Team

Alexandra F.D. Alves, MSc

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Study of CDE100 for Treating Menstrual Cramp Pain in Women With Primary Dysmenorrhea Aged 16 to 35

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria