Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea (LIBERTÀ)

A National, Multicenter, Randomized, Double-blind, Phase III, Crossover Clinical Trial to Assess the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.

The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Drug: DEH113; Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexandra FD Alves, MSc; Phone Number: +551938878917; Email: pesquisa.clinica@ncfarma.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 < 4 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;
• Previous diagnosis of glaucoma;
• Previous diagnosis of kidney and/or liver failure;
• Presence of blood dyscrasias and situations of bone marrow suppression;
• Diagnosis of acute intermittent hepatic porphyria;
• Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);
• Presence of mechanical stenosis in the gastrointestinal tract;
• Previous diagnosis of paralytic ileus or intestinal atony
• Diagnosis of myasthenia gravis;
• Previous diagnosis of severe ulcerative colitis or toxic megacolon complicated with ulcerative colitis
• Participants with a history of alcohol or illicit drug use disorder in the last two (02) years;
• Participants with a current medical history of cancer and/or cancer treatment in the last five (05) years;
• Any finding of clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);
• Participants who are pregnant, nursing or planning to become pregnant;
• Disagreement with the use of a known effective barrier contraceptive method, unless using a stable oral contraceptive for three months or more (which must be maintained throughout the study), or surgically sterile or who expressly declare themselves exempt from risk of pregnancy for not exercising sexual practices or exercising them in a non-reproductive manner;
• Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEH113; The patient must take two (2) DEH113 tablets, if pain, up to three times a day.	Drug: DEH113; Tablets
Placebo Comparator: Control; The patient must take two (2) DEH113 placebo tablets, if pain, up to three times a day.	Drug: Placebo Comparator; Tablets; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose	Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-6 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).	6 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose	Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 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 and 8 hours post-dose
Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose.	Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. The pain intensity will be assessed using a Categorical 4-point scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain).	4, 6 and 8 hours post-dose
Use of rescue medication	Proportion of participants who used rescue medication in the first 24 hours after the first drug intake, amount of rescue medication used in the first 24 hours after the first drug intake, and time elapsed between the last drug intake and the first administration of rescue medication.	24 hours post-dose
Number of additional drug intake	Number of additional drug intake during the 24 hours after the first drug intake	24 hours post-dose
Patients' Global Impression of Change (PGIC)	Patients' Global Impression of Change (PGIC) will be assessed after 8 hours post-dose or immediately before the intake of rescue medication.	8 hours post-dose
Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea	The safety will be evaluated considering the incidence of adverse events (AEs) reported during the study period.	7 days post dose

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: DEH113-III-0123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No