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Not yet recruiting NCT06555549

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

No phase Interventional Primary Dysmenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DEH113, Placebo.
Who it may be relevant to
Registry conditions: Primary Dysmenorrhea. Basic parameters: 16 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug DEH113
    tablets
  • Drug Placebo
    tablets

Primary outcome measures

  • Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose [Time frame: 4, 6 and 8 hours post-dose]
  • Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose [Time frame: 4, 6 and 8 hours post-dose]
Secondary outcome measures (3)
  • Pain intensity (PI) over time [Time frame: 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose]
  • Use of rescue medication [Time frame: 8 hours post-dose]
  • Patients' Global Impression of Change (PGIC) [Time frame: 8 hours post-dose]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06555549 · DEH113-P-0123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗