Clinical trial NCT05810116: Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menstrual Pain
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)
timeFrame: 4 menstrual pain events over a maximum of 16 weeks
Secondary outcomes:
measure: Change in categorical pain levels via categorical pain relief scale
timeFrame: 4 menstrual pain events over a maximum of 16 weeks
measure: Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: 4 menstrual pain events over a maximum of 16 weeks
measure: Change in rescue medication use via self-report
timeFrame: 4 menstrual pain events over a maximum of 16 weeks
measure: Safety of Use
timeFrame: From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks
Other outcomes:
Locations:
city: New Farm
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: