Back to resultsEfficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
Primary Purpose
Endometriosis, Chronic Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
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
Sites / Locations
- University of Cagliari,Obstetrics and Gynecological Department,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endometriosis
Arm Description
Symptomatic patients with laparoscopic diagnosis of endometriosis
Outcomes
Primary Outcome Measures
Change of Pelvic pain as measured by visual analogue scale
Secondary Outcome Measures
Change of Pelvic pain as measured by visual analogue scale
Full Information
NCT ID
NCT02372903
First Posted
February 13, 2015
Last Updated
November 3, 2016
Sponsor
University of Cagliari
1. Study Identification
Unique Protocol Identification Number
NCT02372903
Brief Title
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
Official Title
Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Chronic Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometriosis
Arm Type
Experimental
Arm Description
Symptomatic patients with laparoscopic diagnosis of endometriosis
Intervention Type
Drug
Intervention Name(s)
Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
Intervention Description
Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days
Primary Outcome Measure Information:
Title
Change of Pelvic pain as measured by visual analogue scale
Time Frame
Change from Baseline Pelvic Pain at 90 days of treatment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Cagliari,Obstetrics and Gynecological Department,
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
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