ClinicalTrials.gg
CompletedNCT03419377Updated May 27, 2020

Lichen Sclerosus - the Influence on Quality of Life

An interventional study of Standard care and sexological counseling in Lichen Sclerosus, sponsored by Regionshospital Nordjylland. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by Regionshospital Nordjylland · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Lichen Sclerosus

Keywords

  • Treatment
  • Quality of Life
  • Sexology
  • Women
03

In context

Lichen Sclerosus et Atrophicus

30 studies on the registry are indexed under Lichen Sclerosus et Atrophicus; 8 are open to participants now.

This study's enrollment of 158 is above the median of 45 across 20 interventional studies indexed under Lichen Sclerosus et Atrophicus.

Browse Lichen Sclerosus et Atrophicus studies →

Lead sponsor

Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with Lichen Sclerosus
  • Age over 18 years

Exclusion criteria

Exclusion Criteria:

  • Patients who does not understand or speak Danish
  • Patients with a psychiatric diagnosis and can not follow the course
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
158 participants (actual)

Study arms

  • Experimental
    Standard care and sexological counseling

    Standard care including gynecological examination and 6-8 sexological consultations.

    Other: Standard care and sexological counseling

  • No intervention
    Standard care

    Standard care including gynecological examination.

Interventions

  • OtherStandard care and sexological counseling

    6-8 sexological consultants in a period of six months

06

What researchers measure

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.

    Time frame: Six months

07

Study locations

1 site
  • Vendsyssel Hospital
    Hjørring, 9800, Denmark
08

References and documents

Publications

  • 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. PubMed 35333024 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in May 2020, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 1, 2018
StartActual
Jan 4, 2018
Primary completionActual
May 22, 2020
CompletionActual
May 22, 2020
Last update
May 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03419377
Lead sponsor
Regionshospital Nordjylland
Responsible party
Dorte Melgaard Kristiansen (Research Coordinator, Regionshospital Nordjylland) — Principal investigator
First posted
Feb 1, 2018
Start date
Jan 4, 2018
Primary completion
May 22, 2020
Completion
May 22, 2020
Last update
May 27, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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