Pertubation With Lignocaine in Endometriosis (PLEASE)

Isifer

Status and phase: Completed; Phase 2

Conditions: Dysmenorrhea; Endometriosis

Treatments: Drug: Lignocaine; Drug: Ringers Solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01329796

ISI-06-01

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Pertubation with Endole® (lignocaine)

Experimental group

Description:

Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Treatment:

Drug: Lignocaine

Placebo

Placebo Comparator group

Description:

Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Treatment:

Drug: Ringers Solution