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Pertubation With Lignocaine in Endometriosis (PLEASE)

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Isifer AB
ClinicalTrials.gov Identifier:
NCT01329796
First received: April 4, 2011
Last updated: April 5, 2011
Last verified: April 2011
History of Changes

April 4, 2011
April 5, 2011
March 2007
June 2009   (final data collection date for primary outcome measure)
Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale. [ Time Frame: After three pertubations ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01329796 on ClinicalTrials.gov Archive Site
Quality of life-questionnaire (validated), EHP-30 [ Time Frame: At the 7th menstruation i.e. after approximately 6 months. ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Pertubation With Lignocaine in Endometriosis
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Endometriosis
  • Dysmenorrhea
  • Drug: Lignocaine
    Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
    Other Name: Lidocaine
  • Drug: Ringers Solution
    Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
  • Experimental: Pertubation with Endole® (lignocaine)
    Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
    Intervention: Drug: Lignocaine
  • Placebo Comparator: Placebo
    Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
    Intervention: Drug: Ringers Solution
Wickström K, Bruse C, Sjösten 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. Epub 2012 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
March 2010
June 2009   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01329796
ISI-06-01
Yes
Karin Wickström, Danderyd Hospital, Stockholm, Sweden
Isifer AB
Stockholm County Council, Sweden
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
Isifer AB
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP