Pertubation With Lignocaine in Endometriosis (PLEASE)
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|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|
|Actual Primary Completion Date :||June 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|