Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000015842
Ethics application status
Approved
Date submitted
30/10/2020
Date registered
12/01/2021
Date last updated
19/05/2022
Date data sharing statement initially provided
12/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Population – A double blind, randomised controlled trial.
Scientific title
Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Female Population – A double blind, randomised controlled trial.
Secondary ID [1] 302659 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PEA-MPS20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual Pain 319567 0
Condition category
Condition code
Reproductive Health and Childbirth 317514 317514 0 0
Menstruation and menopause
Alternative and Complementary Medicine 317515 317515 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PEA is a TGA approved ingredient for use in listed medicines in Australia (Brand name Levagen+). PEA + resveratrol (350 mg of Levagen+ (containing no less than 300 mg PEA) and 40 mg of Resveratrol) will be taken as a single capsule twice daily (one in the morning and one in the evening) with water from day 1 of first menstrual month until the end of the 3rd menstrual month. Participants will start to take trial product on day 1 of their next menstrual period following the baseline menstrual period.

Once enrolled, participants will then undergo a health assessment including basic information, lifestyle, medication and medical history. Participants will document their use of any medication (including contraception use) including any use of medication during menses (i.e. pain medication, analgesics, NSAIDs) and complete a self-reported Pittsburg Sleep Quality Index (PQSI) questionnaire.
Following enrolment and health assessment, participants will be provided with their trial product, but instructed to only start supplementation at the required dose once they have recorded data for one full menstrual period. Participants will be provided with their supplements in an opaque bottle containing capsules according to their randomisation. Placebo capsules will appear identical to the active comparator.
This study will consist of a total of 4 menstrual periods being recorded for each participant (1 without supplementation and 3 with supplementation). The first cycle will be recorded prior to any supplementation starting and will count as a baseline/control measure for each participant.
Day 1 will be defined as the first day bleeding occurs. From day 1, participants will complete a visual analogue scale (VAS) and Menstrual Distress Questionnaire Form T (MDQ-T) assessing participant’s menstrual symptoms daily for the duration of each menstrual period (from day 1 of bleeding until bleeding stops). Additionally a Premenstrual Symptom Impact Survey (PMSIS) assessing the impact of premenstrual symptoms on quality of life will be completed at the beginning of each menstrual period (day 1 of the cycle). Additionally, participants will be asked to document any rescue medication used and record any adverse effects encountered whether it be as a result of the treatment or not. At any point during the study, participants may use rescue medication such as ibuprofen or paracetamol, but will need to record any rescue medication they used.
At the end of the study, participation will be considered complete after documentation of symptoms over 4 menstrual cycles (1 without supplementation and 3 with supplementation) as well as completion of a final interview.
Upon completion, participants will undertake a repeat of the baseline assessment (including the PSQI questionnaire) as well as answer a brief questionnaire about their experience as a participant.

Adherence will be monitored by logging of remaining capsules at completion of intervention period.

Intervention code [1] 318946 0
Treatment: Drugs
Comparator / control treatment
The placebo product will be microcrystalline cellulose encapsulated in an opaque capsule. It will appear identical to the test products. The placebo will be administered as 2 capsules using the same procedure detailed above for PEA + resveratrol (one in the morning and one in the evening) for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 325552 0
Changes in monthly pain/severity as assessed by VAS for pain
Timepoint [1] 325552 0
Daily for the duration of each menstrual period - Day 1 to end of menstrual cycle (Final day of 4th menstrual period primary endpoint)
Secondary outcome [1] 388368 0
Changes in rescue medication use as assessed by self-reported questions included in electronic capture of administered questionnaires (PMSIS, MDQ-T).
Timepoint [1] 388368 0
Daily for the duration of each menstrual period - Day 1 to end of menstrual cycle (Max 4 menstrual periods)
Secondary outcome [2] 388369 0
Changes in menstrual symptoms (changes in pain) as measured by VAS scale.
Timepoint [2] 388369 0
Daily for the duration of each menstrual cycle - Day 1 to end of menstrual cycle (Max 4 menstrual periods)
Secondary outcome [3] 388370 0
Changes in premenstrual syndrome (PMS) severity as assessed by PMSIS
Timepoint [3] 388370 0
Day 1 of each menstrual cycle (4 menstrual periods)
Secondary outcome [4] 389347 0
Changes in menstrual symptoms as assessed by the MDQ-T (change in menstrual symptom: bloating as assessed by the MDQ-T)
Timepoint [4] 389347 0
Daily for the duration of each menstrual cycle - Day 1 to end of menstrual cycle (Max 4 menstrual periods)

Eligibility
Key inclusion criteria
- Women who experience mild to moderate menstruating pain
- Aged 18-50 years old
- Otherwise healthy
- Able to provide informed consent
- Regular menstrual cycle (28 days ± 7 days) and period
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Secondary cause for dysmenorrhea (i.e. endometriosis, adenomyosis, uterine fibroids or infection)
- Under or overweight (BMI <18.5 or >35kg/m2)
- Any bleeding disorders, recent surgery or concurrent blood thinning treatment
- Unstable or serious illness (eg kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, lung conditions, chronic asthma, diagnosed psychological or mood disorder)*
- Has or is currently suffering from any form of chronic disease in the past 6 months
- Use of any long-term medication that is related to dysmenorrhea or general pain
- Malignancy or treatment for malignancy within the previous 2 years
- Pregnant or lactating women
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Chronic smokers
- Allergic or hypersensitive to any of the ingredients in active or placebo formula

*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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2021
Date of last participant enrolment
Anticipated
Actual
18/10/2021
Date of last data collection
Anticipated
Actual
23/01/2022
Sample size
Target
120
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307098 0
Commercial sector/Industry
Name [1] 307098 0
Gencor Pacific
Country [1] 307098 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett street
Newstead, Queensland, 4006
Country
Australia
Secondary sponsor category [1] 307667 0
Commercial sector/Industry
Name [1] 307667 0
Gencor Pacific
Address [1] 307667 0
21-E,Elegance
Hillgrove Village
Discovery Bay 999077
Hong Kong
Country [1] 307667 0
Hong Kong
Secondary sponsor category [2] 307668 0
Commercial sector/Industry
Name [2] 307668 0
Pharmako Biotechnologies Pty Ltd
Address [2] 307668 0
36 Campbell Ave, Cromer NSW 2099
Country [2] 307668 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307213 0
Bellberry Limited
Ethics committee address [1] 307213 0
Ethics committee country [1] 307213 0
Australia
Date submitted for ethics approval [1] 307213 0
Approval date [1] 307213 0
03/11/2020
Ethics approval number [1] 307213 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106426 0
Dr David Briskey
Address 106426 0
RDC Global Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 106426 0
Australia
Phone 106426 0
+61 421 784 077
Fax 106426 0
Email 106426 0
[email protected]
Contact person for public queries
Name 106427 0
Amanda Rao
Address 106427 0
RDC Global Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 106427 0
Australia
Phone 106427 0
+61 414 488 559
Fax 106427 0
Email 106427 0
[email protected]
Contact person for scientific queries
Name 106428 0
Amanda Rao
Address 106428 0
RDC Global Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 106428 0
Australia
Phone 106428 0
+61 414 488 559
Fax 106428 0
Email 106428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.