Lichen Sclerosus - the Influence on Quality of Life
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03419377|
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lichen Sclerosus||Other: Standard care and sexological counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Lichen Sclerosus - the Influence on Quality of Life|
|Actual Study Start Date :||January 4, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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 [ 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
|Contact: Dorte Melgaard, firstname.lastname@example.org|
|Contact: Dorthe S Brønnum, MScemail@example.com|
|Hjørring, Denmark, 9800|
|Contact: Dorte Melgaard, phd +4526281086 firstname.lastname@example.org|
|Principal Investigator: Dorte Melgaard, phd|