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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levagen+ | Drug | Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 menstrual pain events over a maximum of 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Rao, PhD | RDC Clinical Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | New Farm | Queensland | 4006 | Australia |
No IPD will be shared
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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| Microcrystalline cellulose | Drug | Daily dose of 1-2 capsules (1 capsule containing 350mg) |
|
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. |
| 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 | 4 menstrual pain events over a maximum of 16 weeks |
| Safety of Use | Safety via Adverse Event reporting | From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |