Status:
NOT_YET_RECRUITING
Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study
Lead Sponsor:
EMS
Conditions:
Primary Dysmenorrhea
Eligibility:
FEMALE
16-35 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06555549
Start Date
September 1 2024
End Date
February 1 2026
Last Update
August 15 2024
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