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

NCT02372903 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-11-04

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis
  • Chronic Pelvic Pain

Interventions

DRUG

Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • Italy

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 NCT02372903 on ClinicalTrials.gov