drugset / Trial / NCT07426640
Dual-Site Botulinum Toxin Type A Injection for Lifelong Premature Ejaculation
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Premature ejaculation is a common sexual condition that can cause distress for men and their partners. Different treatments are available, but some men do not respond well to standard therapies. This study was designed to evaluate whether injecting botulinum toxin type A into two areas of the penis and surrounding muscles can help delay ejaculation in men with lifelong premature ejaculation. Participants were randomly assigned to receive either botulinum toxin injections or placebo injections. The study evaluated ejaculation time, sexual satisfaction, and quality of life over a follow-up period of six months. Safety and possible side effects were also monitored during the study.
Timeline
- Start
- 2021-11-01
- Primary completion
- 2024-11-30
- Completion
- 2024-11-30
Publications
- Results Althof SE, Abdo CH, Dean J, Hackett G, McCabe M, McMahon CG, Rosen RC, Sadovsky R, Waldinger M, Becher E, Broderick GA, Buvat J, Goldstein I, El-Meliegy AI, Giuliano F, Hellstrom WJ, Incrocci L, Jannini EA, Park K, Parish S, Porst H, Rowland D, Segraves R, Sharlip I, Simonelli C, Tan HM; International Society for Sexual Medicine. International Society for Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation. J Sex Med. 2010 Sep;7(9):2947-69. doi: 10.1111/j.1743-6109.2010.01975.x.
- Results Waldinger MD. Premature ejaculation: definition and drug treatment. Drugs. 2007;67(4):547-68. doi: 10.2165/00003495-200767040-00005.
- Results McMahon CG, Althof S, Waldinger MD, Porst H, Dean J, Sharlip I, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJ, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen R, Rowland D, Segraves R; International Society for Sexual Medicine Ad Hoc Committee for Definition of Premature Ejaculation. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int. 2008 Aug;102(3):338-50. doi: 10.1111/j.1464-410X.2008.07755.x. Epub 2008 May 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | — | Other |