Lichen Sclerosus - the Influence on Quality of Life

May 22, 2020 updated by: Dorte Melgaard Kristiansen, Vendsyssel Hospital
A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hjørring, Denmark, 9800
        • Vendsyssel Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vendsyssel Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2018

Primary Completion (Actual)

May 22, 2020

Study Completion (Actual)

May 22, 2020

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHN_DMK_02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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