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Completed

NCT Number: NCT02372903

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

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.

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Key information

Conditions

Endometriosis Chronic Pelvic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Cagliari,Obstetrics and Gynecological Department,

Monserrato, Cagliari, 09042, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

Drug

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

Primary outcomes

  1. Change of Pelvic pain as measured by visual analogue scale

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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