Pertubation With Lignocaine in Endometriosis

Endometriosis Clinical Trial

— PLEASE  

Official title:

Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329796
• Other study ID #: ISI-06-01
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2011
• Last updated: April 5, 2011
• Start date: March 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2011
• Source: Isifer AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Endometriosis

Intervention

Drug:
• Lignocaine
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
• Ringers Solution
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Locations

Country	Name	City	State
Sweden	Department of Gynaecology and Obstetrics Danderyd Hospital	Stockholm
Sweden	Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge	Stockholm
Sweden	Läkargruppen Victoria Söderhallarna 120	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Isifer AB	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After three pertubations	No
Secondary	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.	At the 7th menstruation i.e. after approximately 6 months.	No