ArticleInternational journal of reproductive medicine2022
Assessment of a New Formulation of Sildenafil on Common Practice: An Observational Study.
Article in International journal of reproductive medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Food effect on pharmacokinetic profiles of sildenafil 100 mg oral films in healthy male volunteers: results from two randomized, single dose, crossover studies.Sexual medicine · 2025Article
- Effect of the new 75-mg orodispersible film of sildenafil on erection and sexual quality of life: insights from an observational study.Sexual medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Erectile dysfunction (ED) has a significant impact on the quality of life of patients. Xybilun® (IBSA Pharma SAS, France) is a new formulation of sildenafil in an orodispersible film (ODF). This study aims to assess the response rate (RR), satisfaction with, and safety of sildenafil-ODF in daily practice in France. Patients aged ≥18 years with ED were included in four groups: Group 1 mild, Group 2 moderate, Group 3 severe ED, according to the International Index for Erectile Function (IIEF)-6 subscore, never treated with phosphodiesterase inhibitors (PDE)5-I; Group 4, patients previously treated with another PDE5-I. Patients were evaluated at baseline (V1), one (V2), and three (V3) months. The RR and satisfaction were assessed using the IIEF-6 subscore questionnaire, a 5-point Likert scale, and a Global Assessment Question (GAQ). The primary endpoint for Groups 1 to 3 was the RR according to Rosen criteria at V3 compared to V1. For Group 4, the primary endpoint was the RR, defined as the satisfaction compared with previous treatment. Secondary endpoints were the RR at V2 compared to V1, the evolution of IIEF-6 and IIEF-15 scores, dose adjustment, satisfaction, convenience, and safety. One hundred and five patients were enrolled, 83 analysed. The RR at V3 was 100% (Group 1); 75% (Group 2); 65.2% (Group 3); and 84.2% (Group 4). The overall RR was 78.3%. Secondary parameters confirmed the satisfaction with sildenafil-ODF, with 81.6% of patients very satisfied at V3. No Serious Adverse Events (SAEs) were observed. In conclusion, sildenafil-ODF seems beneficial for patients irrespective of the severity of the ED. This study confirms in the context of daily clinical practice the satisfaction of patients with sildenafil-ODF. Data suggest that the availability of the intermediate dose of 75 mg could add greater flexibility to the therapy.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.