Primary DysmenorrheaPhase 3LIBERTÀNCT06268054
Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea
A Phase 3 study testing DEH113 in people with Primary Dysmenorrhea, run by EMS.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- DEH113
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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
- 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 presence of uncontrolled chronic disease(s);
- Participants who are pregnant, nursing or planning to become pregnant;
- Disagreement with the use of a known effective barrier contraceptive method, unless using a stable oral contraceptive for three months or more (which must be maintained throughout the study), or surgically sterile or who expressly declare themselves exempt from risk of pregnancy for not exercising sexual practices or exercising them in a non-reproductive manner;
- 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;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A National, Multicenter, Randomized, Double-blind, Phase III, Crossover Clinical Trial to Assess the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
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
- Being tested
- DEH113, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEH113Drug
Tablets
Placebo ComparatorDrug
Also called Placebo
Tablets
| Study group | Role | What they receive |
|---|---|---|
| DEH113 | Experimental | The patient must take two (2) DEH113 tablets, if pain, up to three times a day. Receives: Drug: DEH113 |
| Control | Placebo comparator | The patient must take two (2) DEH113 placebo tablets, if pain, up to three times a day. Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 hours post-dose
Secondary outcomes (6)
Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose
Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4 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).
Measured: 4 and 8 hours post-dose
Sum of Pain Intensity Difference (SPID) over 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).
Measured: 4, 6 and 8 hours post-dose
Use of rescue medication
Proportion of participants who used rescue medication in the first 24 hours after the first drug intake, amount of rescue medication used in the first 24 hours after the first drug intake, and time elapsed between the last drug intake and the first administration of rescue medication.
Measured: 24 hours post-dose
Number of additional drug intake
Number of additional drug intake during the 24 hours after the first drug intake
Measured: 24 hours post-dose
Patients' Global Impression of Change (PGIC)
Patients' Global Impression of Change (PGIC) will be assessed after 8 hours post-dose or immediately before the intake of rescue medication.
Measured: 8 hours post-dose
Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea
The safety will be evaluated considering the incidence of adverse events (AEs) reported during the study period.
Measured: 7 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startFeb 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268054
- Sponsor's protocol ID
- DEH113-III-0123
- Acronym
- LIBERTÀ
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multicenter, Randomized, Double-blind, Phase III, Crossover Clinical Trial to Assess the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
- ClinicalTrials.gov ID
- NCT06268054
- Acronym / sponsor ID
- LIBERTÀ / DEH113-III-0123
- Conditions
- Primary Dysmenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEH113 | Experimental | Drug: DEH113The patient must take two (2) DEH113 tablets, if pain, up to three times a day. |
| Control | Placebo comparator | Drug: Placebo ComparatorThe patient must take two (2) DEH113 placebo tablets, if pain, up to three times a day. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEH113Tablets | Drug | DEH113 |
| Placebo ComparatorAlso: PlaceboTablets | Drug | Control |
Primary outcome
Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose
Time frame: 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 secondary outcomes
Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose
Time frame: 4 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
Use of rescue medication
Time frame: 24 hours post-dose
Number of additional drug intake
Time frame: 24 hours post-dose
Patients' Global Impression of Change (PGIC)
Time frame: 8 hours post-dose
Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea
Time frame: 7 days post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DEH113 in people with Primary Dysmenorrhea, run by EMS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra FD Alves, MSc (+551938878917, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose (time frame: 6 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.