A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Summary

This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.

Timeline

Start

2013-08-07

Primary completion

2017-08-15

Completion

2017-08-15

Outcome

Missed primary endpoint

Stopped (Business): “Strategic business decision was made to terminate the program. There were no safety concerns.”

registry analysis (superiority test); OnabotulinumtoxinA Dose 1 vs Placebo; p = 0.393; Least square mean difference 0.11 NCT01917006 ↗

registry analysis (superiority test); OnabotulinumtoxinA Dose 2 vs Placebo; p = 0.263; Least Square Mean Difference 0.25 NCT01917006 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	5 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Intramuscular

Indications