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

PEAMPS-23

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.

2023-05-19

2025-06-01

2025-08-01

Recruiting

Early phase I

80

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 1. 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.

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2023-11-18