Pertubation With Lignocaine in Endometriosis

Phase 2

Completed

• Conditions: Endometriosis; Dysmenorrhea
• Interventions: Drug: Ringers Solution; Drug: Lignocaine

• Registration Number: NCT01329796
• Lead Sponsor: Isifer AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2009-06
• Study Completion: 2010-03
• Status Verified: 2011-04
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Last Update Submitted: 2011-04-05
• Study First Posted: 2011-04-06
• Last Update Posted: 2011-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Ringers Solution	Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Pertubation with Endole® (lignocaine)	Lignocaine	Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Läkargruppen Victoria Söderhallarna 120; 🇸🇪 Stockholm, Sweden

Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge; 🇸🇪 Stockholm, Sweden

Department of Gynaecology and Obstetrics Danderyd Hospital; 🇸🇪 Stockholm, Sweden