Menstrual PainPhase 4NCT05810116
Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain
A Phase 4 study testing Levagen+ and Microcrystalline cellulose in people with Menstrual Pain, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menstrual Pain
- What is being tested?
- Levagen+ and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 19 May 2023to 20 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Levagen+, Microcrystalline cellulose
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levagen+Drug
Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)
Microcrystalline celluloseDrug
Daily dose of 1-2 capsules (1 capsule containing 350mg)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 menstrual pain events over a maximum of 16 weeks
Secondary outcomes (4)
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)
Measured: 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)
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.
Measured: 4 menstrual pain events over a maximum of 16 weeks
Change in rescue medication use via self-report
Change in rescue medication use via self-report
Measured: 4 menstrual pain events over a maximum of 16 weeks
Safety of Use
Safety via Adverse Event reporting
Measured: From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start19 May 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual PainStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810116
- Sponsor's protocol ID
- PEAMPS-23
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05810116
- Acronym / sponsor ID
- PEAMPS-23
- Conditions
- Menstrual Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 19 May 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levagen+ | Active comparator | Drug: Levagen+PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists. |
| Microcrystalline cellulose | Placebo comparator | Drug: Microcrystalline cellulosePEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levagen+Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA) | Drug | Levagen+ |
| Microcrystalline celluloseDaily dose of 1-2 capsules (1 capsule containing 350mg) | Drug | Microcrystalline cellulose |
Primary outcome
Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)
Time frame: 4 menstrual pain events over a maximum of 16 weeks
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 secondary outcomes
Change in categorical pain levels via categorical pain relief scale
Time frame: 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)
Time frame: 4 menstrual pain events over a maximum of 16 weeks
Change in rescue medication use via self-report
Time frame: 4 menstrual pain events over a maximum of 16 weeks
Safety of Use
Time frame: From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levagen+ and Microcrystalline cellulose in people with Menstrual Pain, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS) (time frame: 4 menstrual pain events over a maximum of 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.