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

Primary Dysmenorrhea Clinical Trial

— LIBERTÀ  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06268054
• Other study ID #: DEH113-III-0123
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2025
• Est. completion date: September 2027

Study information

• Verified date: February 2024
• Source: EMS
• Contact: Alexandra FD Alves, MSc
• Phone: +551938878917
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: September 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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;

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Drug:
• DEH113
Tablets
• Placebo Comparator
Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of additional drug intake	Number of additional drug intake during the 24 hours after the first drug intake	24 hours post-dose
Secondary	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
Secondary	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