Sildenafil orodispersible film patient-centred experience in the treatment of erectile dysfunction: an observational, prospective, multicentre cohort study (18I-SDF01)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Prospective observational cohort study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SILDENAFIL CITRATE
• Medical condition to be studied:
  Erectile dysfunction

Population studied

• Short description of the study population:
  Erectile dysfunction patients.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  525

Study design details

• Main study objective:
  To gather information on a patient-centred experience with the new formulation of Sildenafil IBSA ODF, and on the new, intermediate 75 mg dose, in the treatment of ED of different origins.
• Outcomes:
  Change from Visit 1 to Visit 3 in the Erectile Function Domain of the 15-item International Index of Erectile Function (IIEF-EF score), effectiveness, patient’s preference, and satisfaction, time to onset of pharmacological effects, treatment safety, patient's evaluation of the ease-of-use
• Data analysis plan:
  Safety Set (SS):data analysis for the safety outcome measures will be performed using data of all enrolled patients for whom evidence of treatment can be documented. Full Analysis Set (FAS): primary and secondary outcome measures will be analysed using data of all enrolled patients. Per Protocol set (PP): a sensitivity analysis using all of the subjects who completed the study.