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

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endometriosis Chronic Pelvic Pain Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
Study Start Date : October 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Polydatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Endometriosis
Symptomatic patients with laparoscopic diagnosis of endometriosis
 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


Outcome Measures
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Primary Outcome Measures :
  1. Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from Baseline Pelvic Pain at 90 days of treatment ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372903


Locations
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Italy
University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, Italy, 09042
Sponsors and Collaborators
University of Cagliari
More Information
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Responsible Party: Stefano Angioni, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT02372903    
Other Study ID Numbers: PELV_25
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Pain
Neurologic Manifestations
Palmidrol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Anti-Inflammatory Agents
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists