Tadalafil (LY450190) compared to Sildenafil in Patients with ED

• Research type

  Research Study

• Full title

  Impact of Tadalafil (LY450190) Once a Day or Tadalafil On Demand Compared to Sildenafil Citrate On Demand on Treatment Discontinuation in Patients with Erectile Dysfunction who are Naïve to PDE5 Inhibitors

• IRAS ID

  43516

• Contact name

  Varsha Vasi

• Sponsor organisation

  Eli Lilly and Company Limited

• Eudract number

  2009-011318-22

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is a Phase 4 study in men with erectile dysfunction (the inability to maintain an erection) that have not been treated with this type of medication before. The study medication, called tadalafil, is a PDE-5 inhibitor and this type of medication improves erectile response in these patients by improving blood flow to the muscles of the penis in response to sexual stimulation. This study will look at the impact of two different doses of tadalafil compared with another drug, sildenafil citrate. Participants in this study will be allocated to one of three treatment groups - tadalafil once daily, tadalafil on demand or sildenafil citrate on demand. The total treatment period will be 6 months. After the first 8 weeks of treatment there is the possibility of participants switching to one of the other study treatments. Participants will be asked to complete questionnaires relating to their sexual activity throughout the study. Approximately 780 participants will be entered into the study worldwide.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  10/H0906/16

• Date of REC Opinion

  16 Apr 2010

• REC opinion

  Further Information Favourable Opinion