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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02372903

Enrollment

Registered

2015-02-26

Start date

2013-10-31

Completion date

2015-09-30

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pelvic Pain, 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.

Interventions

DRUGAdministration 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change of Pelvic pain as measured by visual analogue scale	Change from Baseline Pelvic Pain at 90 days of treatment

Secondary

Measure	Time frame
Change of Pelvic pain as measured by visual analogue scale	Change from baseline Pelvic Pain after 30 days from the suspension of the therapy

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026