Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study
- Conditions
- Primary Dysmenorrhea
- Interventions
- Drug: Placebo
- Registration Number
- NCT06555549
- Lead Sponsor
- EMS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DEH113 DEH113 The patient must take two (2) DEH113 tablets in a single dose, if pain. Placebo Placebo The patient must take two (2) placebo tablets in a single dose, if pain.
- Primary Outcome Measures
Name Time Method Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose 4, 6 and 8 hours post-dose Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 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).
Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose 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).
- Secondary Outcome Measures
Name Time Method Patients' Global Impression of Change (PGIC) 8 hours post-dose Patients' Global Impression of Change (PGIC) will be assessed after 8 hours post-dose or immediately before the intake of rescue medication
Pain intensity (PI) over time 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose PI score assessed 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose
Use of rescue medication 8 hours post-dose Proportion of participants who used rescue medication in the first 8 hours after the first drug intake and time elapsed between the last drug intake and the first administration of rescue medication.