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

University of Cagliari30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometriosis Chronic Pelvic Pain

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of Pelvic pain as measured by visual analogue scale

Time frame: Change from Baseline Pelvic Pain at 90 days of treatment

Secondary Outcomes