Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

NCT05810116 | Completed Phase 4

• 1 other identifier: PEAMPS-23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstrual Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in categorical pain levels via categorical pain relief scale

  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)

  4 menstrual pain events over a maximum of 16 weeks

• Change in rescue medication use via self-report

  4 menstrual pain events over a maximum of 16 weeks

• Safety of Use

  From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks

Study Arms (2)

Levagen+

ACTIVE COMPARATOR

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+

Microcrystalline cellulose

PLACEBO COMPARATOR

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

Interventions

Levagen+ DRUG

Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)

Levagen+

Microcrystalline cellulose DRUG

Daily dose of 1-2 capsules (1 capsule containing 350mg)

Microcrystalline cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

New Farm, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 12, 2023
• Study Start: May 19, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: November 14, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)