Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Pain
• Intervention / Treatment: Drug: Levagen+; Drug: Microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • New Farm, Queensland, Australia, 4006
      • RDC Clinical Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levagen+; PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.	Drug: Levagen+; Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)
Placebo Comparator: 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.	Drug: Microcrystalline cellulose; Daily dose of 1-2 capsules (1 capsule containing 350mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)	Reduction in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS) a pain assessment tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The higher the score the worse the pain.	4 menstrual pain events over a maximum of 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in categorical pain levels via categorical pain relief scale	Reduction in categorical pain levels via categorical pain relief scale (better, much better, no change, worse, much worse)	4 menstrual pain events over a maximum of 16 weeks
Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM)	Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM). To assess the overall level of satisfaction or dissatisfaction with medication patients are taking. Higher scores indicate higher satisfaction.	4 menstrual pain events over a maximum of 16 weeks
Change in rescue medication use via self-report	Change in rescue medication use via self-report	4 menstrual pain events over a maximum of 16 weeks
Safety of Use	Safety via Adverse Event reporting	From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea
• Other Study ID Numbers: PEAMPS-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No