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

Not Applicable

Completed

• Conditions: Endometriosis; Chronic Pelvic Pain
• Interventions: Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

• Registration Number: NCT02372903
• Lead Sponsor: University of Cagliari

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-21
• Study First Posted: 2015-02-26
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endometriosis	Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin	Symptomatic patients with laparoscopic diagnosis of endometriosis

Primary Outcome Measures

Name	Time	Method
Change of Pelvic pain as measured by visual analogue scale	Change from Baseline Pelvic Pain at 90 days of treatment

Secondary Outcome Measures

Name	Time	Method
Change of Pelvic pain as measured by visual analogue scale	Change from baseline Pelvic Pain after 30 days from the suspension of the therapy

Trial Locations

Locations (1)

University of Cagliari,Obstetrics and Gynecological Department,; 🇮🇹 Monserrato, Cagliari, Italy