Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Endometriosis
Dysmenorrhea
Drug: Lignocaine
Drug: Ringers Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study

Resource links provided by NLM:


Further study details as provided by Isifer AB:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 42
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329796

Locations
Sweden
Department of Gynaecology and Obstetrics Danderyd Hospital
Stockholm, Sweden, 182 88
Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge
Stockholm, Sweden, 141 86
Läkargruppen Victoria Söderhallarna 120
Stockholm, Sweden, 118 72
Sponsors and Collaborators
Isifer AB
Stockholm County Council, Sweden
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
  More Information

No publications provided by Isifer AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karin Wickström, Danderyd Hospital, Stockholm, Sweden
ClinicalTrials.gov Identifier: NCT01329796     History of Changes
Other Study ID Numbers: ISI-06-01
Study First Received: April 4, 2011
Last Updated: April 5, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Isifer AB:
dysmenorrhea,
pelvic pain
dyspareunia
endometriosis

Additional relevant MeSH terms:
Dysmenorrhea
Endometriosis
Genital Diseases, Female
Menstruation Disturbances
Pain
Pathologic Processes
Pelvic Pain
Signs and Symptoms
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 19, 2014