Clinical Trial: A Safety and Efficacy Study of BOTOX® in Premature Ejaculation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
Brief Summary: This is a safety and efficacy study of BOTOX® (onabotulinumtoxinA) for the treatment of premature ejaculation in male patients.
Detailed Summary:
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of BOTOX for the treatment of male patients with PE. Patients 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 IELT.
Patients will be enrolled in cohorts. Within the first 5 cohorts, 8 patients are to receive BOTOX and 2 patients to receive placebo. For cohort 6, 12 patients will receive BOTOX and 12 patients will receive placebo. Patients will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial BOTOX total dose in this dose escalation study will be 5 U and the maximum BOTOX total dose will be 100 U. Upon request and if eligible, patients in cohort 6, will have the option to receive a second injection of BOTOX (open label).
Sponsor: Allergan
Current Primary Outcome: Change from Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Baseline, Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from Baseline in Average IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, and 12 ]
- Change from Baseline in Geometric Mean IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, and 10 ]
Original Secondary Outcome: Same as current
Information By: Allergan
Dates:
Date Received: August 2, 2013
Date Started: August 2013
Date Completion: December 2017
Last Updated: October 3, 2016
Last Verified: October 2016