Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain
Menstrual Pain
About this trial
This is an interventional treatment trial for Menstrual Pain
Eligibility Criteria
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.
Sites / Locations
- RDC Clinical Pty Ltd
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Levagen+
Microcrystalline cellulose
PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.
PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.