Lichen Sclerosus - the Influence on Quality of Life
1 other identifier
interventional
158
1 country
1
Brief Summary
A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2018
CompletedFirst Submitted
Initial submission to the registry
January 26, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2020
CompletedMay 27, 2020
May 1, 2020
2.4 years
January 26, 2018
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life in women with Lichen Sclerosus
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.
Six months
Study Arms (2)
Standard care and sexological counseling
EXPERIMENTALStandard care including gynecological examination and 6-8 sexological consultations.
Standard care
NO INTERVENTIONStandard care including gynecological examination.
Interventions
6-8 sexological consultants in a period of six months
Eligibility Criteria
You may qualify if:
- Patients diagnosed with Lichen Sclerosus
- Age over 18 years
You may not qualify if:
- Patients who does not understand or speak Danish
- Patients with a psychiatric diagnosis and can not follow the course
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vendsyssel Hospital
Hjørring, 9800, Denmark
Related Publications (1)
Vittrup G, Westmark S, Riis J, Morup L, Heilesen T, Jensen D, Melgaard D. The Impact of Psychosexual Counseling in Women With Lichen Sclerosus: A Randomized Controlled Trial. J Low Genit Tract Dis. 2022 Jul 1;26(3):258-264. doi: 10.1097/LGT.0000000000000669. Epub 2022 Mar 25.
PMID: 35333024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Coordinator
Study Record Dates
First Submitted
January 26, 2018
First Posted
February 1, 2018
Study Start
January 4, 2018
Primary Completion
May 22, 2020
Study Completion
May 22, 2020
Last Updated
May 27, 2020
Record last verified: 2020-05