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NCT03419377 Clinical Trial

Lichen Sclerosus - the Influence on Quality of Life

Lichen Sclerosus Clinical Trial

Official title:
Lichen Sclerosus - the Influence on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03419377
Other study ID # RHN_DMK_02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2018
Est. completion date May 22, 2020

Study information
Verified date May 2020
Source Vendsyssel Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

The patients are randomized to an intervention Group and a control Group. The intervention gets 6-8 visits with clinical sexologist and the control Group is having the usual care.

Recruitment information / eligibility
Status Completed
Enrollment 158
Est. completion date May 22, 2020
Est. primary completion date May 22, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients diagnosed with Lichen Sclerosus

- Age over 18 years

Exclusion Criteria:

- Patients who does not understand or speak Danish

- Patients with a psychiatric diagnosis and can not follow the course

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Standard care and sexological counseling
6-8 sexological consultants in a period of six months

Locations
Country Name City State
Denmark Vendsyssel Hospital Hjørring

Sponsors (1)
Lead Sponsor Collaborator
Vendsyssel Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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