Women 20-40 years of age with endometriosis and pelvic pain will be included in this study. MedDRA version: 8.1 Level: LLT Classification code 10014788 Term: Endometriosis related pain
Conditions
Interventions
Trade Name: Endole
Product Name: Endole
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: lidokainhydroklorid
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
Karolinska Institute, Danderyds hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Women 20-40 years, Endometriosis verified by laparoscopy, Dysmenorrhea or pelvic pain, , defined as having a pain-score of >5 at the visual analogue scale(VAS), Normal Fallopian tubes, Regular menstruation bleeding (If not on hormonal treatment she should have been without combined contraceptive pills or gestagens for 1 month or without GnRH-agonists for at least 6 months, Treatment with oral contraceptives should have been ongoing for at least 1 month and shall continue during the trial), No wish for pregnancy at present, Normal Pap-smear, Negative Chlamydia-test Negative pregnancy-test. Informed consent given and signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criterias: Continous treatment with NSAID, corticosteroids or other medicine that may increase risk for infection, Clinical signs of pelvic inflammatory disease, Known hyperreactivity to local anesthesia, Fibriods>2cm, Ongoing treatment with GnRH-analog, Ongoing continous treatment with gestagens, Pregnancy or wish for pregnancy the forthcoming year, Pelvic adhesions, Verified occluded or reduced patency in the 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to study the safety and tolerability of preovulatory pertubation with lignocaine in a dose of 1.0 mg/ml and to study the effect of pertubation with Ringer-Lignocaine in a dose of 1.0 mg/ml on quality of life in patients with endometriosis. ;Primary end point(s): The primary criterion for evaluation is a Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale. The primary time point for primary efficacy evaluation is after the last pertubation (corresponding to 4th menstruation i.e. approximately 3 months after initial treatment);Main Objective: The primary purpose of the study is to study the effect of pertubation with Ringer-Lignocaine in a dose of 1.0 mg/ml on dysmenorrhea, pelvic pain and dyspareunia in patients with endometriosis. | — |
Countries
Sweden
Outcome results
None listed