Lichen Sclerosus - the Influence on Quality of Life
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|ClinicalTrials.gov Identifier: NCT03419377|
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lichen Sclerosus||Other: Standard care and sexological counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Lichen Sclerosus - the Influence on Quality of Life|
|Actual Study Start Date :||January 4, 2018|
|Actual Primary Completion Date :||May 22, 2020|
|Actual Study Completion Date :||May 22, 2020|
Experimental: Standard care and sexological counseling
Standard care including gynecological examination and 6-8 sexological consultations.
Other: Standard care and sexological counseling
6-8 sexological consultants in a period of six months
No Intervention: Standard care
Standard care including gynecological examination.
- Quality of Life in women with Lichen Sclerosus [ Time Frame: Six months ]Change in EuroQol five dimension (EQ-5D) score. The descriptive system comprises 5 dimensions (mobili-ty, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.
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): NCT03419377
|Hjørring, Denmark, 9800|