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Pertubation With Lignocaine in Endometriosis

NCT01329796 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-04-06

No results posted yet for this study

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.

Conditions

  • Endometriosis
  • Dysmenorrhea

Interventions

DRUG

Lignocaine

Intrauterine flushing, pertubation, three treatments 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.

Sponsors & Collaborators

  • Region Stockholm

    collaborator OTHER_GOV

  • Isifer AB

    lead INDUSTRY

Principal Investigators

  • Karin Wickström, MD · Danderyd Hospital, SE-182 88 Stockholm, Sweden

  • Greta Edelstam, MD · Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-06-30
Completion
2010-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329796 on ClinicalTrials.gov