E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women 20-40 years of age with endometriosis and pelvic pain will be included in this study. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014788 |
E.1.2 | Term | Endometriosis related pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A pharmacokinetic evaluation of the active ingredient (lidocaine) will be performed at study center no 01, Danderyds hospital |
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E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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All subjects will obtain three treatments and subsequently intermittently be followed for a total duration of approximately 12 months following the first menstruation after inclusion in the study (approx. 13 menstrual periods). The end of trial is defined as last subjects last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |