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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)
Daily dose of 1-2 capsules (1 capsule containing 350mg)
RDC Clinical Pty Ltd
New Farm, Queensland, Australia
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.
Time frame: 4 menstrual pain events over a maximum of 16 weeks
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)
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)
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
Change in rescue medication use via self-report
Change in rescue medication use via self-report
Time frame: 4 menstrual pain events over a maximum of 16 weeks
Safety of Use
Safety via Adverse Event reporting
Time frame: From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks
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