Liver DiseasesNCT04896723
Sexual Dysfunction in Patients With Chronic Liver Disease
An observational study of Liver Diseases and Liver Cirrhosis, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Diseases, Liver Cirrhosis
- What is being tested?
- Sexual function questionnaire
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with chronic liver disease
Who may be able to join
- Diagnosis of a chronic liver disease (including those who have had liver transplantation)
- Aged 18-75
- Able to give informed written consent
Who cannot join
- Major psychiatric disease
- Patients who lack capacity
- Patient with no chronic liver disease
- Patients not proficient in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Liver Studies
London, SE5 9RS
Mussarat Rahim, MBBS BSc MRCP, 02032994241, mussaratrahim@nhs.net
Refah Z Ahmed, BA MSc, 02032997150, refah.ahmed1@nhs.net
About this study
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.
- Conditions
- Liver Diseases, Liver Cirrhosis
- Being tested
- Sexual function questionnaire
- Medical subject headings
- Liver Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual function questionnaireDiagnostic test
Sexual function questionnaire and cognitive screening assessments
| Study group | Role | What they receive |
|---|---|---|
| Chronic liver disease | Not described Receives: Diagnostic Test: Sexual function questionnaire | |
| Healthy volunteers | Not described Receives: Diagnostic Test: Sexual function questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with sexual dysfunction
The number of patients suffering from sexual dysfunction in patients with chronic liver disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896723
- Sponsor's protocol ID
- 272717
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT04896723
- Acronym / sponsor ID
- 272717
- Conditions
- Liver Diseases, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic liver disease | – | Diagnostic Test: Sexual function questionnaire |
| Healthy volunteers | – | Diagnostic Test: Sexual function questionnaire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease
Key inclusion criteria (3 listed)
- Diagnosis of a chronic liver disease (including those who have had liver transplantation)
- Aged 18-75
- Able to give informed written consent
Key exclusion criteria (4 listed)
- Major psychiatric disease
- Patients who lack capacity
- Patient with no chronic liver disease
- Patients not proficient in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual function questionnaireSexual function questionnaire and cognitive screening assessments | Diagnostic test | Chronic liver disease, Healthy volunteers |
Primary outcome
Number of patients with sexual dysfunction
Time frame: 12 months
The number of patients suffering from sexual dysfunction in patients with chronic liver disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Cirrhosis, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mussarat Rahim, MBBS BSc MRCP (02032994241, mussaratrahim@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with sexual dysfunction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.