Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RDC Clinical Pty Ltd

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

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.