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

University of Cagliari

Status: Completed

Conditions: Chronic Pelvic Pain; Endometriosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02372903

PELV_25

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Endometriosis

Experimental group

Description:

Symptomatic patients with laparoscopic diagnosis of endometriosis

Treatment:

Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin