Efficacy of Intracavernosal 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

Summary

The primary objective of this study is to investigate the efficacy of intracavernosal (Xeomin®) (100U) as add-on therapy to sildenafil 100 mg on demand in men with ED and insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week open-label run-in phase. The secondary objectives are to further describe the efficacy and safety of (Xeomin®) 100U IC as add-on therapy to sildenafil 100 mg on demand: 1. to further assess efficacy using. * i) a log diary five-item questionnaire completed after each sexual attempt (Sexual Encounter Profile); * ii) a self-reporting measure that scores erection hardness on a 4 point scale completed after each sexual attempt; * iii) The Global Assessment Question. 2. to assess effect persistence at month 6 and month 9. 3. to assess safety of (Xeomin®) 100U IC in combination with sildenafil 100 mg on demand.

Timeline

Start

2022-03-18

Primary completion

2024-07-23

Completion

2024-11-15

Outcome

Missed primary endpoint

paper Intention-to-treat (ITT) analysis showed no significant improvement in IIEF-EF score with incobotulinumtoxinA 100 U combined with sildenafil 100 mg at 3 months. PMID 40971935 ↗

paper IncobotulinumtoxinA 100 U improved penetration (SEP-Q2) and erection maintenance (SEP-Q3), but not significantly. PMID 40971935 ↗

Publications

• Background 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.
• Background 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.
• Giuliano F, Denormandie AC, Madec FX, Carnicelli D, Graziana JP, Droupy S, Marcelli F, Gassama M, Grimaldi L; MENOX study group. Efficacy and safety of intracavernosal incobotulinumtoxinA (Xeomin) as add-on therapy to sildenafil for the treatment of erectile dysfunction insufficiently responsive to phosphodiesterase type 5 inhibitors. J Sex Med. 2025 Nov 2;22(11):1994-2001. doi: 10.1093/jsxmed/qdaf225.
• Giuliano F, Denys P, Joussain C. Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin(R)) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series. Toxins (Basel). 2022 Apr 16;14(4):286. doi: 10.3390/toxins14040286.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Other

Indications