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NCT05196308: MENOX
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
Phase 2 trial testing Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH) in Erectile Dysfunction in 226 participants. Completed in 15 November 2024.
23 July 2024
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 226 |
| Start date | 18 March 2022 |
| Primary completion | 23 July 2024 |
| Estimated completion | 15 November 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH) — full drug profile →
- Placebo administration — full drug profile →
Conditions studied
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 80, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin<sup>®</sup>) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series.
Giuliano F, Denys P, Joussain C. · · 2022 · cited 10× · PMID 35448895 · DOI 10.3390/toxins14040286
Verify or expand the search:
- PubMed search for NCT05196308
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Erectile Dysfunction
Currently open trials in the same condition.
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- NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05196308 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05196308.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing