Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study

NCT ID: NCT06555549

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-02-28

Brief Summary

This study aims to evaluate the preliminary efficacy and safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated with Primary Dysmenorrhea.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DEH113

The patient must take two (2) DEH113 tablets in a single dose, if pain.

Group Type: EXPERIMENTAL

DEH113

Intervention Type: DRUG

tablets

Placebo

The patient must take two (2) placebo tablets in a single dose, if pain.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

tablets

Interventions

DEH113

tablets

Intervention Type: DRUG

Placebo

tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has given written informed consent to participate in the study before admission to the study;
• Female patients aged between 16 and 35 years old, inclusive;
• History of regular menstrual cycles, occurring 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 < 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;
• 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);
• Previous diagnosis of acute intermittent hepatic porphyria;
• 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
• Treatment with psychoactive drugs (such as for example, antidepressants, antipsychotics, etc.) in the 30 days prior to selection for the study;
• 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 the presence of uncontrolled chronic disease(s);
• Participants who are pregnant, nursing, or planning to become pregnant;
• 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;

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alexandra FD Alves

Role: CONTACT

pesquisa.clinica@ncfarma.com.br

1938878917

Other Identifiers

DEH113-P-0123

Identifier Type: -

Identifier Source: org_study_id