Primary Dysmenorrhea
Conditions
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.
Interventions
DRUGDEH113
tablets
DRUGPlacebo
tablets
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 35 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Contacts
Primary ContactAlexandra FD Alves
Outcome results
None listed