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Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis

CompletedNot applicableNCT02372903
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia. N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.

Study details

Official title
Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
Interventions
  • Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
Sponsor
University of Cagliari
Start date
2013-10
Primary completion
2015-08
Sex
Female
Age range
from 18 Years to 50 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Italy
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * age between 18 and 50 years; * pain visual analog scale (VAS) score\>4 * laparoscopic diagnosis of endometriosis (performed in the last three years), * no assumption of any drugs (in particularly estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists) * persistence of symptoms by at least one month Exclusion Criteria: * presence of other associated diseases * assumption of drugs * menopause * pregnancy * unable or unwilling to give written consent patients * adverse reaction or hypersensitivity to active substance or excipients

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02372903