Pertubation With Lignocaine in Endometriosis
PLEASE
1 other identifier
interventional
42
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2007
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedApril 6, 2011
April 1, 2011
2.3 years
April 4, 2011
April 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Quality of life-questionnaire (validated), EHP-30
At the 7th menstruation i.e. after approximately 6 months.
Study Arms (2)
Pertubation with Endole® (lignocaine)
EXPERIMENTALThree treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Placebo
PLACEBO COMPARATORPertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Interventions
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Isifer ABlead
- Region Stockholmcollaborator
Study Sites (3)
Läkargruppen Victoria Söderhallarna 120
Stockholm, Stockholm County, 118 72, Sweden
Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge
Stockholm, Stockholm County, 141 86, Sweden
Department of Gynaecology and Obstetrics Danderyd Hospital
Stockholm, Stockholm County, 182 88, Sweden
Related Publications (3)
Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
PMID: 28844356DERIVEDWickstrom K, Spira J, Edelstam G. Serum concentration of lignocaine after pertubation: an observational study. Drugs R D. 2013 Sep;13(3):235-9. doi: 10.1007/s40268-013-0022-8.
PMID: 23921822DERIVEDWickstrom K, Bruse C, Sjosten A, Spira J, Edelstam G. Pertubation with lignocaine as a new treatment of dysmenorrhea due to endometriosis: a randomized controlled trial. Hum Reprod. 2012 Mar;27(3):695-701. doi: 10.1093/humrep/der434. Epub 2012 Jan 9.
PMID: 22232129DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 4, 2011
First Posted
April 6, 2011
Study Start
March 1, 2007
Primary Completion
June 1, 2009
Study Completion
March 1, 2010
Last Updated
April 6, 2011
Record last verified: 2011-04