| NCT ID | NCT05428267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sexual Dysfunction in Patients With Cirrhosis Awaiting Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-05-26 |
| Primary Completion | 2026-07-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-05-26 with a primary completion date of 2026-07-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The prevalence of erectile dysfunction (ED) is about 10% in the general population, but increases with age, ranging from 9.1% in men 40-49 years to 55% in men \>70. The major risk factors for ED are as follows: diabetes; heart conditions; tobacco use; obesity; injuries to the nerves that control erection; medications such as antidepressants; psychological conditions such as stress, anxiety, or depression; and drug or alcohol use (4). The International Index of Erectile Function (IIEF5) is a simple and well-validated tool for the evaluation of ED (5) and is considered the gold standard for the diagnosis and evaluation of symptom severity. The link between cirrhosis and ED has been suggested in a recent study, showing ED was also impacted by liver failure, portal hypertension and other known risk factors. In the investigators team, they showed, additionally, that neurocognitive impairment is associated with ED in cirrhosis (data not published). The prevalence of ED after liver transplantation (LT) varies among series, ranging from 66 to 86%. After LT, on the one hand, improvement of liver function and bioavailable testosterone favours the improvement of ED. On the other hand, immunosuppressive agents are suspected to worsen it. ED's reversibility has also been discussed; nevertheless, data are scarce and heterogeneous. In the investigators group, they can perform in routine a neurocognitive evaluation of patients with cirrhosis thanks to a neuropsychologist experienced in cognitive disorders occurring in patients with cirrhosis. The aims of this study are: 1) to compare the prevalence of erectile dysfunction (ED) in a population of patients with cirrhosis before liver transplantation (LT) and one year after LT; (2) to describe factors associated with ED before and after LT, with a special focus of hormonal profile, neurocognitive impairment, multimodal brain Magnetic resonance imaging (MRI) and of the type of immunosuppressive therapy used; (3) to assess the impact of ED on sexual partner; (4) to evaluate the efficacy of the treatment with phosphodiesterase-5 inhibitors (PDE-5) drugs after LT. Methods: neurocognitive tests will be performed by an expert neuropsychologist. Biological evaluation will include an evaluation of liver function, hormonal assessment (bioavailable testosterone). MRI acquisition protocol will include anatomical sequences (3D-T1, FLAIR, T2, T2 \*), diffusion tensor imaging (DTI) and two single voxel MR spectroscopy acquisitions. Evaluation will be performed before LT and 1 year after LT.
Eligibility Criteria
Inclusion Criteria: * (1) cirrhosis; (2) non-urgent indication for LT. Exclusion Criteria: * (1) clinical HE; (2) dementia; (3) language barrier; (4) past history of prostatic surgery
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05428267 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sexual Dysfunction in Patients With Cirrhosis Awaiting Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05428267 currently recruiting?
Yes, NCT05428267 is actively recruiting participants. Contact the research team at marika.rudler@aphp.fr for enrollment information.
Where is the NCT05428267 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05428267 clinical trial?
NCT05428267 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 150 participants.