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

Официальное название

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

Обзор

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

Вмешательства

• Препарат DEH113
  tablets
• Препарат Placebo
  tablets

Первичные конечные точки

• Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose [Срок оценки: 4, 6 and 8 hours post-dose]
• Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose [Срок оценки: 4, 6 and 8 hours post-dose]

Вторичные конечные точки (3)

• Pain intensity (PI) over time [Срок оценки: 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose]
• Use of rescue medication [Срок оценки: 8 hours post-dose]
• Patients' Global Impression of Change (PGIC) [Срок оценки: 8 hours post-dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06555549 · DEH113-P-0123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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