A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.
Full Title of Study: “Lichen Sclerosus – the Influence on Quality of Life”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 22, 2020
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.
- Other: Standard care and sexological counseling
- 6-8 sexological consultants in a period of six months
Arms, Groups and Cohorts
- Experimental: Standard care and sexological counseling
- Standard care including gynecological examination and 6-8 sexological consultations.
- No Intervention: Standard care
- Standard care including gynecological examination.
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Vendsyssel Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Dorte Melgaard Kristiansen, Research Coordinator – Vendsyssel Hospital
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