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

NCT02372903 | Completed

• 1 other identifier: PELV_25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Change of Pelvic pain as measured by visual analogue scale

  Change from Baseline Pelvic Pain at 90 days of treatment

Secondary Outcomes (1)

• Change of Pelvic pain as measured by visual analogue scale

  Change from baseline Pelvic Pain after 30 days from the suspension of the therapy

Study Arms (1)

Endometriosis

EXPERIMENTAL

Symptomatic patients with laparoscopic diagnosis of endometriosis

Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

Interventions

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

Endometriosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

University of Cagliari,Obstetrics and Gynecological Department,

Monserrato, Cagliari, 09042, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 26, 2015
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

IT (1)