Pertubation With Lignocaine in Endometriosis (PLEASE)
|ClinicalTrials.gov Identifier: NCT01329796|
Recruitment Status : Completed
First Posted : April 6, 2011
Last Update Posted : April 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis Dysmenorrhea||Drug: Lignocaine Drug: Ringers Solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study|
|Study Start Date :||March 2007|
|Primary Completion Date :||June 2009|
|Study Completion Date :||March 2010|
Experimental: Pertubation with Endole® (lignocaine)
Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
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.
- Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale. [ Time Frame: After three pertubations ]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.
- Quality of life-questionnaire (validated), EHP-30 [ Time Frame: At the 7th menstruation i.e. after approximately 6 months. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329796
|Läkargruppen Victoria Söderhallarna 120|
|Stockholm, Sweden, 118 72|
|Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge|
|Stockholm, Sweden, 141 86|
|Department of Gynaecology and Obstetrics Danderyd Hospital|
|Stockholm, Sweden, 182 88|
|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|