Effect of the new 75-mg orodispersible film of sildenafil on erection and sexual quality of life: insights from an observational study.

"Conflicts of interest : E.A.J. is/has been a consultant and/or paid speaker for Bayer, IBSA, Menarini, Merck-Serono, Otsuka, Pfizer Inc, Shionogi, and viatris. V.F. and A.L. are full-time employees of IBSA. has no conflicts of interest. C.C. has been a consultant and/or paid speaker for Dompè Primary, Menarini, Takeda, Alphremev, and SOFAR. M.D.S. is/has been a paid speaker for Janssen, Astellas, and Leonardo Medica. V.M. has been a consultant and/or paid speaker for SR, Recordati, Janssen. A.C., C.I., L.S., and C.T. have no conflicts of interest to declare."

"Funding IBSA Institut Biochimique SA (Lugano, Switzerland) provided financial support for the study and for the publication of this work. A.S. and E.A.J. have also been partially supported for this work by the Italian Ministry of University PRIN (grant # 2017S9KTNE_002). Conflicts of interest: E.A.J. is/has been a consultant and/or paid speaker for Bayer, IBSA, Menarini, Merck-Serono, Otsuka, Pfizer Inc, Shionogi, and viatris. V.F. and A.L. are full-time employees of IBSA. has no conflicts of interest. C.C. has been a consultant and/or paid speaker for Dompè Primary, Menarini, Takeda, Alphremev, and SOFAR. M.D.S. is/has been a paid speaker for Janssen, Astellas, and Leonardo Medica. V.M. has been a consultant and/or paid speaker for SR, Recordati, Janssen. A.C., C.I., L.S., and C.T. have no conflicts of interest to declare."

"This observational study was designed and monitored with consideration of the ethical principles of the International Conference on Harmonisation (ICH), the Declaration of Helsinki and its amendments, and the current guidelines for observational trials. The study was registered on the European Union Electronic Register of Post-Authorisation Studies (EU PAS Register, study reference: EUPAS25496) and submitted to the reference Ethics Committee of each participating site. Due to the observational nature of the study, a control group was not included. All subjects were asked to take the prescribed dose of sildenafil ODF (Rabestrom, IBSA; the product is registered in other countries with the following brand names: Silandyl, Silvir, and Xybilun) at study entry (visit 1) and to return for a control visit (visit 2) to confirm or adapt the prescribed dose after a minimum of 4 weeks. An end-of-study control visit (visit 3) was performed after an additional 4 weeks. Patients were encouraged to attempt sexual intercourse using the drug on at least 8 occasions during the period between visits."