Pertubation With Lignocaine in Endometriosis (PLEASE)

April 5, 2011 updated by: Isifer AB

Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study

Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. A double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 118 72
        • Läkargruppen Victoria Söderhallarna 120
      • Stockholm, Sweden, 141 86
        • Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge
      • Stockholm, Sweden, 182 88
        • Department of Gynaecology and Obstetrics Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age > 20 years
  • endometriosis verified by laparoscopy
  • dysmenorrhea or pelvic pain defined as a pain-score of >50 mm (VAS)
  • normal Fallopian tubes
  • regular menstrual cycles 21-35 days
  • treatment with oral contraceptives (OC) ongoing > 1 month and continued during the trial
  • previous hormonal treatment discontinued > 1 month (OC, gestagens) and > 6 months (GnRH)
  • no wish for pregnancy during the study
  • normal Pap-smear
  • negative Chlamydia-test
  • negative pregnancy-test
  • informed consent given and signed

Exclusion Criteria:

  • Continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease
  • hyperreactivity to local anesthesia
  • fibroids > 2 cm
  • ongoing treatment with GnRH-analog
  • ongoing continuous treatment with high dose gestagens
  • pregnancy
  • peritubal adhesions
  • occluded Fallopian tubes
  • inability to understand information or comply with the study procedures
  • participation in a clinical study within one year before the present study
  • any disease or laboratory finding considered of importance by the investigator not to include the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pertubation with Endole® (lignocaine)
Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Drug: Lignocaine
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Other Names:
  • Lidocaine
Placebo Comparator: Placebo
Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Drug: Ringers Solution
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
Time Frame: After three pertubations
The pain-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatments=baseline for evaluation) and thereafter during 2nd, 3rd, 4 th, 7th, 10th and 13th menstrual periods.
After three pertubations

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life-questionnaire (validated), EHP-30
Time Frame: At the 7th menstruation i.e. after approximately 6 months.
The Quality of life-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatment=baseline for evaluation) and thereafter during 7th and 13th menstrual period.
At the 7th menstruation i.e. after approximately 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isifer AB

Collaborators

Region Stockholm

Investigators

  • Principal Investigator: Karin Wickström, MD, Danderyd Hospital, SE-182 88 Stockholm, Sweden
  • Study Director: Greta Edelstam, MD, Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-06-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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