Sexual Dysfunction in Cirrhosis

Study acronym: SEDYC
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Jul 26, 2026 → Jul 26, 2028
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Record History

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  1. Notable Primary and study completion pushed from Jul 26, 2026 to Jul 26, 2028 Show 4 more changesShow less
    • Enrollment increased: 150 → 230 participants
    • Study description expanded, about 10 words
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  2. Notable Primary and study completion dates: Jan 26, 2026 to Jul 26, 2026v7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Minor Primary and study completion dates: Nov 26, 2025 to Jan 26, 2026v5
  5. Notable Primary and study completion dates: Nov 26, 2024 to Nov 26, 2025
    • Secondary endpoints: details revised at 4 of 4 entries
    v4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jan 1, 2024 to Nov 26, 2024
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 1, 2023 to May 26, 2023
    v3
  2. Notable Start date: Jul 1, 2022 to Apr 1, 2023v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05428267
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Sexual Dysfunction in Patients With Cirrhosis Awaiting Liver Transplantation
Related terms Fibrosis, Sexual Dysfunction, Physiological
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov