Overview
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.
Eligibility
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.