Palmitoylethanolamide (Levagen+) for acute menstrual pain: a randomized, crossover, double-blind, placebo-controlled trial
Randomised controlled trialHumans
- Design
- Randomised controlled trial
- Subjects
- 80 Australian women (18 and over) with mild to moderate primary dysmenorrhoea enrolled; 73 recorded at least one pain event; 217 pain events analysed (103 PEA, 114 placebo)
- Dose used in the study
- One capsule of Levagen+ 350 mg (at least 300 mg PEA) or microcrystalline cellulose placebo at pain onset (NRS 5 or more), with a second capsule at 2 hours if pain persisted
- Duration
- Up to 4 pain events per woman over 16 weeks, in randomised crossover order; each event followed for 4 hours
- What was measured
- Numerical pain rating every 30 minutes for 4 hours; pain resolution; Treatment Satisfaction Questionnaire for Medication; rescue medication; adverse events
What the authors reported
Pain scores were lower on PEA than placebo at 1, 1.5, 2 and 2.5 hours (p = 0.045, 0.009, 0.015, 0.039), about 25 percent lower at 2.5 hours. No difference appeared at 3 to 4 hours, in the number of events resolved, in satisfaction scores, in rescue medication use or in adverse events (5 on PEA, 3 on placebo).
Limits of this study
Telehealth trial with self-reported diary data. The effect was present for 1.5 hours and gone by 3 hours. Events where rescue medication was taken within 4 hours were excluded (31 events). Hormonal contraceptive users were included. Product supplied by Gencor, the Levagen+ manufacturer; the authors' company runs trials for Gencor. Registered NCT05810116.
Source
doi:10.1080/03630242.2025.2458243
Entry checked against the full text, supplied by Devlin on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.