---
title: "Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study"
nct_id: NCT06555549
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: EMS
study_type: INTERVENTIONAL
primary_condition: Primary Dysmenorrhea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06555549.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06555549"
ct_last_update_post_date: 2024-08-15
last_seen_at: "2026-05-12T06:43:33.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06555549](https://clinicaltrials.gov/study/NCT06555549)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** EMS
- **Conditions:** Primary Dysmenorrhea
- **Start Date:** 2024-09
- **Completion Date:** 2026-02
- **CT.gov Last Update:** 2024-08-15

## 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

- **Minimum age:** 16 Years
- **Maximum age:** 35 Years
- **Sex:** FEMALE
- **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;
```

## Arms

- **DEH113** (EXPERIMENTAL) — The patient must take two (2) DEH113 tablets in a single dose, if pain.
- **Placebo** (PLACEBO_COMPARATOR) — The patient must take two (2) placebo tablets in a single dose, if pain.

## Interventions

- **DEH113** (DRUG) — tablets
- **Placebo** (DRUG) — tablets

## Primary Outcomes

- **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)_ — 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** _(time frame: 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 Outcomes

- **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)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06555549.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06555549*  
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