NCT04896723

Brief Summary

This project will determine the incidence of sexual dysfunction in patients with chronic liver disease, through questionnaires. The questionnaires have been designed to assess several facets of sexual health, e.g. libido, physical symptoms, depression, etc. 150 patients in our liver outpatient department, and 150 healthy volunteers will be asked to fill in the questionnaire in paper form. The results of this project will be used to produce patient resources, advice sheets and educational materials for patients with chronic liver disease. There is also scope to consider possible interventions in the future to improve sexual dysfunction in patients with chronic liver disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

May 5, 2021

Last Update Submit

May 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients with sexual dysfunction

    The number of patients suffering from sexual dysfunction in patients with chronic liver disease

    12 months

Study Arms (2)

Chronic liver disease

Diagnostic Test: Sexual function questionnaire

Healthy volunteers

Diagnostic Test: Sexual function questionnaire

Interventions

Sexual function questionnaire and cognitive screening assessments

Chronic liver diseaseHealthy volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic liver disease

You may qualify if:

  • Diagnosis of a chronic liver disease (including those who have had liver transplantation)
  • Aged 18-75
  • Able to give informed written consent

You may not qualify if:

  • Major psychiatric disease
  • Patients who lack capacity
  • Patient with no chronic liver disease
  • Patients not proficient in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver Studies

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Liver DiseasesLiver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mussarat Rahim, MBBS BSc MRCP

CONTACT

Refah Z Ahmed, BA MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 21, 2021

Study Start

June 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

May 21, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations