NCT01917006

A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Allergan · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of OnabotulinumtoxinA for the treatment of male participants with PE. Participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. Partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (IELT). Participants will be enrolled in cohorts. Within the first 5 cohorts, 8 participants are to receive OnabotulinumtoxinA and 2 participants to receive placebo. For cohort 6, 12 participants will receive OnabotulinumtoxinA and 12 participants will receive placebo. Participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial OnabotulinumtoxinA total dose in this dose escalation study will be 5 U and the maximum OnabotulinumtoxinA total dose will be 100 U. Upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of OnabotulinumtoxinA (Open-label).

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
DRUG	Normal Saline	Placebo (normal saline) injected into specified muscle per protocol on Day 1.

Timeline

• Start date: 2013-08-07
• Primary completion: 2017-08-15
• Completion: 2017-08-15
• First posted: 2013-08-06
• Last updated: 2018-10-18
• Results posted: 2018-10-18

Locations

10 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study