EndometriosisNCT02372903
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
A study testing Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin in people with Endometriosis and Chronic Pelvic Pain, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Chronic Pelvic Pain
- What is being tested?
- Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, 09042
About this study
Official title: Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
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.
- Conditions
- Endometriosis, Chronic Pelvic Pain
- Being tested
- Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of micronized Palmitoylethanolamide (PEA)- TranspolydatinDrug
Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Experimental | Symptomatic patients with laparoscopic diagnosis of endometriosis Receives: Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pelvic pain as measured by visual analogue scale
Measured: Change from Baseline Pelvic Pain at 90 days of treatment
Secondary outcomes (1)
Change of Pelvic pain as measured by visual analogue scale
Measured: Change from baseline Pelvic Pain after 30 days from the suspension of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372903
- Sponsor's protocol ID
- PELV_25
- Status last verified
- Nov 2016
- First submitted
- 13 Feb 2015
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
- ClinicalTrials.gov ID
- NCT02372903
- Acronym / sponsor ID
- PELV_25
- Conditions
- Endometriosis, Chronic Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | Experimental | Drug: Administration of micronized Palmitoylethanolamide (PEA)- TranspolydatinSymptomatic patients with laparoscopic diagnosis of endometriosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- presence of other associated diseases
- assumption of drugs
- menopause
- pregnancy
- unable or unwilling to give written consent patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of micronized Palmitoylethanolamide (PEA)- TranspolydatinPalmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days | Drug | Endometriosis |
Primary outcome
Change of Pelvic pain as measured by visual analogue scale
Time frame: Change from Baseline Pelvic Pain at 90 days of treatment
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin in people with Endometriosis and Chronic Pelvic Pain, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pelvic pain as measured by visual analogue scale (time frame: Change from Baseline Pelvic Pain at 90 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.