Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
Overview
- Phase
- Not Applicable
- Intervention
- Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
- Conditions
- Endometriosis
- Sponsor
- University of Cagliari
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change of Pelvic pain as measured by visual analogue scale
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Stefano Angioni
Associate Professor
University of Cagliari
Eligibility Criteria
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
Arms & Interventions
Endometriosis
Symptomatic patients with laparoscopic diagnosis of endometriosis
Intervention: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
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
- Change of Pelvic pain as measured by visual analogue scale(Change from baseline Pelvic Pain after 30 days from the suspension of the therapy)