Clinical trial NCT06555549: Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study
Official title: A National, Multicenter, Randomized, Double-blind, Single-dose, Crossover Clinical Trial to Preliminary Evaluate the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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;

Primary outcomes:
measure: Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose
timeFrame: 4, 6 and 8 hours post-dose
measure: Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose
timeFrame: 4, 6 and 8 hours post-dose
Secondary outcomes:
measure: Pain intensity (PI) over time
timeFrame: 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose
measure: Use of rescue medication
timeFrame: 8 hours post-dose
measure: Patients' Global Impression of Change (PGIC)
timeFrame: 8 hours post-dose
Other outcomes:
Locations:
Study officials:
References: