Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05810116




Registration number
NCT05810116
Ethics application status
Date submitted
27/03/2023
Date registered
12/04/2023
Date last updated
18/11/2023

Titles & IDs
Public title
Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain
Scientific title
Effect of Palmitoylethanolamide (PEA) Compared to a Placebo on Acute Menstrual Pain in an Adult Population - A Double-blind, Crossover, Randomised Controlled Trial.
Secondary ID [1] 0 0
PEAMPS-23
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual Pain 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levagen+
Treatment: Drugs - Microcrystalline cellulose

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.

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.


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

Treatment: Drugs: Microcrystalline cellulose
Daily dose of 1-2 capsules (1 capsule containing 350mg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)
Timepoint [1] 0 0
4 menstrual pain events over a maximum of 16 weeks
Secondary outcome [1] 0 0
Change in categorical pain levels via categorical pain relief scale
Timepoint [1] 0 0
4 menstrual pain events over a maximum of 16 weeks
Secondary outcome [2] 0 0
Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM)
Timepoint [2] 0 0
4 menstrual pain events over a maximum of 16 weeks
Secondary outcome [3] 0 0
Change in rescue medication use via self-report
Timepoint [3] 0 0
4 menstrual pain events over a maximum of 16 weeks
Secondary outcome [4] 0 0
Safety of Use
Timepoint [4] 0 0
From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - New Farm
Recruitment postcode(s) [1] 0 0
4006 - New Farm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05810116
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
amanda@rdcglobal.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05810116