Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

RDC Clinical

Status and phase: Completed; Phase 4

Conditions: Menstrual Pain

Treatments: Drug: Microcrystalline cellulose; Drug: Levagen+

Study type: Interventional

Funder types: Industry

Identifiers

NCT05810116

PEAMPS-23

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Levagen+

Active Comparator group

Description:

PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.

Treatment:

Drug: Levagen+

Microcrystalline cellulose

Placebo Comparator group

Description:

PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.

Treatment:

Drug: Microcrystalline cellulose