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

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.

Full Title of Study: “Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

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

Arms, Groups and Cohorts

  • Experimental: Endometriosis
    • Symptomatic patients with laparoscopic diagnosis of endometriosis

Clinical Trial Outcome Measures

Primary Measures

  • Change of Pelvic pain as measured by visual analogue scale
    • Time Frame: Change from Baseline Pelvic Pain at 90 days of treatment

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Cagliari
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stefano Angioni, Associate Professor – University of Cagliari

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