|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
14 November 2016 |
|
Main ID: |
NCT02372903 |
|
Date of registration:
|
13/02/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
|
|
Scientific title:
|
Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis |
|
Date of first enrolment:
|
October 2013 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02372903 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Pelvic Pain
|
|
Endometriosis
|
|
Intervention(s)
|
|
Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
|
|
Primary Outcome(s)
|
|
Change of Pelvic pain as measured by visual analogue scale
[Time Frame: Change from Baseline Pelvic Pain at 90 days of treatment]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|