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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372903
• Other study ID #: PELV_25
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: November 3, 2016
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2016
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Endometriosis
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
Italy	University of Cagliari,Obstetrics and Gynecological Department,	Monserrato	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pelvic pain as measured by visual analogue scale		Change from Baseline Pelvic Pain at 90 days of treatment	No
Secondary	Change of Pelvic pain as measured by visual analogue scale		Change from baseline Pelvic Pain after 30 days from the suspension of the therapy	No