Lichen Sclerosus - the Influence on Quality of Life

NCT ID: NCT03419377

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2020-05-22

Brief Summary

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A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.

Detailed Description

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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.

Conditions

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Lichen Sclerosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard care and sexological counseling

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

Group Type EXPERIMENTAL

Standard care and sexological counseling

Intervention Type OTHER

6-8 sexological consultants in a period of six months

Standard care

Standard care including gynecological examination.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Standard care and sexological counseling

6-8 sexological consultants in a period of six months

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regionshospital Nordjylland

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dorte Melgaard Kristiansen

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vendsyssel Hospital

Hjørring, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 35333024 (View on PubMed)

Other Identifiers

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RHN_DMK_02

Identifier Type: -

Identifier Source: org_study_id

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