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

EMS

Status: Not yet enrolling

Conditions: Primary Dysmenorrhea

Treatments: Drug: Placebo; Drug: DEH113

Study type: Interventional

Funder types: Industry

Identifiers

NCT06555549

DEH113-P-0123

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

DEH113

Experimental group

Description:

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

Treatment:

Drug: DEH113

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo