Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea

NCT06268054 | Not Yet Recruiting Phase 3

• 1 other identifier: DEH113-III-0123
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose

  Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-6 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).

  6 hours post-dose

Secondary Outcomes (6)

• Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose

  4 and 8 hours post-dose

• Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose.

  4, 6 and 8 hours post-dose

• Use of rescue medication

  24 hours post-dose

• Number of additional drug intake

  24 hours post-dose

• Patients' Global Impression of Change (PGIC)

  8 hours post-dose

Study Arms (2)

DEH113

EXPERIMENTAL

The patient must take two (2) DEH113 tablets, if pain, up to three times a day.

Drug: DEH113

Control

PLACEBO COMPARATOR

The patient must take two (2) DEH113 placebo tablets, if pain, up to three times a day.

Drug: Placebo Comparator

Interventions

DEH113 DRUG

Tablets

DEH113

Placebo Comparator DRUG

Tablets

Also known as: Placebo

Control

Eligibility Criteria

• Age: 16 Years - 35 Years
• Gender Eligibility Details: Women with moderate to severe pain associated with primary dysmenorrhea.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient has given written informed consent to participate in the study prior to admission to the study;
• Female patients aged between 16 and 35 years old, inclusive;
• History of regular menstrual cycles, occuring 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.

You may not qualify if:

• 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 \< 4 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);
• Presence of mechanical stenosis in the gastrointestinal tract;

Sponsors & Collaborators

• EMS: lead

Central Study Contacts

Alexandra FD Alves, MSc

CONTACT

+551938878917; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share