Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

Study Overview
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Brief Summary
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This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Palmitoylethanolamide (PEA) compared to placebo on menstrual pain in otherwise healthy participants 18 years and over.

Official Title
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Effect of Palmitoylethanolamide (PEA) Compared to a Placebo on Acute Menstrual Pain in an Adult Population - A Double-blind, Crossover, Randomised Controlled Trial.

Conditions
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Menstrual Pain

Intervention / Treatment
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* Drug: Levagen+
* Drug: Microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who experience mild to moderate menstruating pain Aged 18 years or over History of over the counter (OTC) analgesic use for the treatment of menstrual pain Self-reported history of menstrual cramp pain occurring during four of the past six menstrual cycles. Typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, ibuprofen or acetaminophen taken on at least 1 day of menstrual cycle for the treatment of mild to moderate menstrual cramp, and normally experiences pain relief from these medications. Otherwise healthy Able to provide informed consent Regular menstrual cycle (28 days ± 7 days) and period Agree not to participate in any other clinical trial while enrolled in this trial Exclusion Criteria: Secondary cause for dysmenorrhea (i.e. endometriosis, adenomyosis, uterine fibroids or infection) Any bleeding disorders, recent surgery or concurrent blood thinning treatment Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder) (1) Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy Pregnant or lactating women Active smokers, nicotine use or drug (prescription or illegal substances) abuse Chronic past and/or current alcohol use (>14 alcoholic drinks week) Allergic or hypersensitive to any of the ingredients in active or placebo formula Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion Participated in any other clinical trial during the past 1 month An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levagen+<br>PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists. | Drug: Levagen+<br>* Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)<br>|
| Placebo Comparator: Microcrystalline cellulose<br>PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists. | Drug: Microcrystalline cellulose<br>* Daily dose of 1-2 capsules (1 capsule containing 350mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS) | Reduction in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS) a pain assessment tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable. The higher the score the worse the pain. | 4 menstrual pain events over a maximum of 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in categorical pain levels via categorical pain relief scale | Reduction in categorical pain levels via categorical pain relief scale (better, much better, no change, worse, much worse) | 4 menstrual pain events over a maximum of 16 weeks | 
| Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM) | Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM). To assess the overall level of satisfaction or dissatisfaction with medication patients are taking. Higher scores indicate higher satisfaction. | 4 menstrual pain events over a maximum of 16 weeks | 
| Change in rescue medication use via self-report | Change in rescue medication use via self-report | 4 menstrual pain events over a maximum of 16 weeks | 
| Safety of Use | Safety via Adverse Event reporting | From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks |