NCT05196308 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Fisher WA, Gruenwald I, Jannini EA, Lev-Sagie A, Lowenstein L, Pyke RE, Reisman Y, Revicki DA, Rubio-Aurioles E
Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction. J Sex Med. 2017 Jan;14(1):3-18. doi: 10.1016/j.jsxm.2016.08.016.
Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K
Validation of the erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34. doi: 10.1111/j.1743-6109.2007.00600.x. Epub 2007 Sep 21.

Efficacy of Intracavernosal (Xeomin®) 100U as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibitors

Details for clinical trial NCT05196308

Clinical trial NCT05196308 - References