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Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

Primary Purpose

Menstrual Pain

Status
Not yet recruiting
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Levagen+
Microcrystalline cellulose
Sponsored by
RDC Clinical Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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.

Sites / Locations

  • RDC Clinical Pty Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levagen+

Microcrystalline cellulose

Arm Description

PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.

PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
Change in rescue medication use via self-report
Change in rescue medication use via self-report
Safety of Use
Safety via Adverse Event reporting

Full Information

First Posted
March 27, 2023
Last Updated
April 10, 2023
Sponsor
RDC Clinical Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05810116
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RDC Clinical Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levagen+
Arm Type
Active Comparator
Arm Description
PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.
Arm Title
Microcrystalline cellulose
Arm Type
Placebo Comparator
Arm Description
PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.
Intervention Type
Drug
Intervention Name(s)
Levagen+
Intervention Description
Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)
Intervention Type
Drug
Intervention Name(s)
Microcrystalline cellulose
Intervention Description
Daily dose of 1-2 capsules (1 capsule containing 350mg)
Primary Outcome Measure Information:
Title
Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)
Description
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.
Time Frame
4 menstrual pain events over a maximum of 16 weeks
Secondary Outcome Measure Information:
Title
Change in categorical pain levels via categorical pain relief scale
Description
Reduction in categorical pain levels via categorical pain relief scale (better, much better, no change, worse, much worse)
Time Frame
4 menstrual pain events over a maximum of 16 weeks
Title
Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM)
Description
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.
Time Frame
4 menstrual pain events over a maximum of 16 weeks
Title
Change in rescue medication use via self-report
Description
Change in rescue medication use via self-report
Time Frame
4 menstrual pain events over a maximum of 16 weeks
Title
Safety of Use
Description
Safety via Adverse Event reporting
Time Frame
From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Rao, PhD
Phone
+61 414 488 559
Email
amanda@rdcglobal.com.au
First Name & Middle Initial & Last Name or Official Title & Degree
David Briskey, PhD
Phone
+61 421 784 077
Email
david@rdcglobal.com.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Rao, PhD
Organizational Affiliation
RDC Clinical Pty Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
RDC Clinical Pty Ltd
City
New Farm
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Rao, PhD
Phone
+61 414 488 559
Email
amanda@rdcglobal.com.au
First Name & Middle Initial & Last Name & Degree
David Briskey, PhD
Phone
+61 421 784 077
Email
david@rdcglobal.com.au

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared

Learn more about this trial

Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

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