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

NCT05640232 | Recruiting Phase 3 DMC

• 1 other identifier: EMS0522 - ASTRAL
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Sum of Total Pain Relief (TOTPAR) over 0-4 hours post-dose.

  Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).

  4 hours post-dose.

Secondary Outcomes (9)

• Sum of Total Pain Relief (TOTPAR) over 0-8 hours post-dose.

  8 hours post-dose.

• Sum of Pain Intensity Difference (SPID) over 4 hours post-dose.

  4 hours post-dose.

• Sum of Pain Intensity Difference (SPID) over 8 hours post-dose.

  8 hours post-dose.

• Time to first intake of rescue medication.

  Up to 8 hours post-dose.

• Patients who used rescue medication.

  Up to 8 hours post-dose.

Study Arms (2)

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.

Drug: CDE100 association

Control

ACTIVE COMPARATOR

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.

Drug: Buscopan® Composto association

Interventions

CDE100 association DRUG

Experimental drug.

Experimental

Buscopan® Composto association DRUG

Active comparator.

Control

Eligibility Criteria

• Age: 16 Years - 35 Years
• Gender Eligibility Details: Women with moderate to severe pain associated with primary dysmenorrhea.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of gastrointestinal bleeding or perforation related to the use of NSAIDs;
• Presence of compromised bone marrow function or diseases of the hematopoietic system;
• Diagnosis of acute intermittent hepatic porphyria;
• Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);
• Diagnosis of untreated angle-closure glaucoma;

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

EMS

Hortolândia, São Paulo, Brazil

RECRUITING

Central Study Contacts

Alexandra F.D. Alves, MSc

CONTACT

+551938878917; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, Double-dummy.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: June 11, 2025
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)