Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

Menstrual Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810116
• Other study ID #: PEAMPS-23
• Status: Recruiting
• Phase: Phase 4
• Start date: May 19, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2023
• Source: RDC Clinical Pty Ltd
• Contact: Amanda Rao, PhD
• Phone: +61 414 488 559
• Email: amanda[@]rdcglobal.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Menstrual Pain

Intervention

Drug:
• Levagen+
Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)
• Microcrystalline cellulose
Daily dose of 1-2 capsules (1 capsule containing 350mg)

Locations

Country	Name	City	State
Australia	RDC Clinical Pty Ltd	New Farm	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Safety of Use	Safety via Adverse Event reporting	From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks