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

• ClinicalTrials.gov Identifier: NCT02372903
• Recruitment Status: Completed
• First Posted: February 26, 2015
• Last Update Posted: November 4, 2016
• Sponsor: University of Cagliari
• Information provided by (Responsible Party): Stefano Angioni, University of Cagliari

Tracking Information

• First Submitted Date: February 13, 2015
• First Posted Date: February 26, 2015
• Last Update Posted Date: November 4, 2016
• Study Start Date: October 2013
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 21, 2015): Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from Baseline Pelvic Pain at 90 days of treatment ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 21, 2015): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Endometriosis
• Chronic 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

Study Arms

Experimental: Endometriosis

Symptomatic patients with laparoscopic diagnosis of endometriosis

Intervention: Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 21, 2015): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02372903
• Other Study ID Numbers: PELV_25
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stefano Angioni, University of Cagliari
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Cagliari
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Cagliari
• Verification Date: November 2016