Pertubation With Lignocaine in Endometriosis (PLEASE)
This study has been completed.
Sponsor:
Isifer AB
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Isifer AB
ClinicalTrials.gov Identifier:
NCT01329796
First received: April 4, 2011
Last updated: April 5, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometriosis Dysmenorrhea |
Drug: Lignocaine Drug: Ringers Solution |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study |
Resource links provided by NLM:
Further study details as provided by Isifer AB:
Primary Outcome Measures:
- Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale. [ Time Frame: After three pertubations ] [ Designated as safety issue: No ]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:
- Quality of life-questionnaire (validated), EHP-30 [ Time Frame: At the 7th menstruation i.e. after approximately 6 months. ] [ Designated as safety issue: No ]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.
| Enrollment: | 42 |
| Study Start Date: | March 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pertubation with Endole® (lignocaine)
Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
|
Drug: Lignocaine
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Other Name: Lidocaine
|
|
Placebo Comparator: Placebo
Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
|
Drug: Ringers Solution
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329796
Locations
| Sweden | |
| Department of Gynaecology and Obstetrics Danderyd Hospital | |
| Stockholm, Sweden, 182 88 | |
| Läkargruppen Victoria Söderhallarna 120 | |
| Stockholm, Sweden, 118 72 | |
| Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge | |
| Stockholm, Sweden, 141 86 | |
Sponsors and Collaborators
Isifer AB
Stockholm County Council, Sweden
Investigators
| Principal Investigator: | Karin Wickström, MD | Danderyd Hospital, SE-182 88 Stockholm, Sweden |
| Study Director: | Greta Edelstam, MD | Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden |
More Information
No publications provided by Isifer AB
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Karin Wickström, Danderyd Hospital, Stockholm, Sweden |
| ClinicalTrials.gov Identifier: | NCT01329796 History of Changes |
| Other Study ID Numbers: | ISI-06-01 |
| Study First Received: | April 4, 2011 |
| Last Updated: | April 5, 2011 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Isifer AB:
|
dysmenorrhea, pelvic pain dyspareunia endometriosis |
Additional relevant MeSH terms:
|
Dysmenorrhea Endometriosis Menstruation Disturbances Pathologic Processes Pelvic Pain Pain Signs and Symptoms Genital Diseases, Female Lidocaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013