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Pertubation With Lignocaine in Endometriosis (PLEASE)

Primary Purpose

Endometriosis, Dysmenorrhea

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Lignocaine
Ringers Solution
Sponsored by
Isifer AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring dysmenorrhea,, pelvic pain, dyspareunia, endometriosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Läkargruppen Victoria Söderhallarna 120
  • Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge
  • Department of Gynaecology and Obstetrics Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pertubation with Endole® (lignocaine)

Placebo

Arm Description

Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Outcomes

Primary Outcome Measures

Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
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.

Secondary Outcome Measures

Quality of life-questionnaire (validated), EHP-30
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.

Full Information

First Posted
April 4, 2011
Last Updated
April 5, 2011
Sponsor
Isifer AB
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01329796
Brief Title
Pertubation With Lignocaine in Endometriosis
Acronym
PLEASE
Official Title
Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Isifer AB
Collaborators
Region Stockholm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Dysmenorrhea
Keywords
dysmenorrhea,, pelvic pain, dyspareunia, endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pertubation with Endole® (lignocaine)
Arm Type
Experimental
Arm Description
Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Intervention Type
Drug
Intervention Name(s)
Lignocaine
Other Intervention Name(s)
Lidocaine
Intervention Description
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Intervention Type
Drug
Intervention Name(s)
Ringers Solution
Intervention Description
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Primary Outcome Measure Information:
Title
Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
Description
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.
Time Frame
After three pertubations
Secondary Outcome Measure Information:
Title
Quality of life-questionnaire (validated), EHP-30
Description
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.
Time Frame
At the 7th menstruation i.e. after approximately 6 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Wickström, MD
Organizational Affiliation
Danderyd Hospital, SE-182 88 Stockholm, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Greta Edelstam, MD
Organizational Affiliation
Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Läkargruppen Victoria Söderhallarna 120
City
Stockholm
ZIP/Postal Code
118 72
Country
Sweden
Facility Name
Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Department of Gynaecology and Obstetrics Danderyd Hospital
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28844356
Citation
Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
Results Reference
derived
PubMed Identifier
23921822
Citation
Wickstrom K, Spira J, Edelstam G. Serum concentration of lignocaine after pertubation: an observational study. Drugs R D. 2013 Sep;13(3):235-9. doi: 10.1007/s40268-013-0022-8.
Results Reference
derived
PubMed Identifier
22232129
Citation
Wickstrom K, Bruse C, Sjosten A, Spira J, Edelstam G. Pertubation with lignocaine as a new treatment of dysmenorrhea due to endometriosis: a randomized controlled trial. Hum Reprod. 2012 Mar;27(3):695-701. doi: 10.1093/humrep/der434. Epub 2012 Jan 9.
Results Reference
derived

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Pertubation With Lignocaine in Endometriosis

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