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Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

NCT05810116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-14

No results posted yet for this study

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.

Conditions

  • Menstrual Pain

Interventions

DRUG

Levagen+

Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)

DRUG

Microcrystalline cellulose

Daily dose of 1-2 capsules (1 capsule containing 350mg)

Sponsors & Collaborators

  • RDC Clinical Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Amanda Rao, PhD · RDC Clinical Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2023-12-20
Completion
2023-12-20

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05810116 on ClinicalTrials.gov