Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Population – A double blind, randomised controlled trial.

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.