Study of the Safety and Efficacy of Botox® for the Treatment of PE
Research type
Research Study
Full title
An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
IRAS ID
132174
Contact name
David Ralph
Contact email
Sponsor organisation
Allergan Limited
Eudract number
2013-001650-94
Research summary
This study will explore the safety and efficacy of a range of doses of BOTOX for the treatment of Premature Ejaculation (PE) in male patients.\n\nMen aged between 18 and 50 years in a stable monogamous sexual relationship with a\nfemale partner, who have PE as defined by the 2008 ISSM guidelines and who meet the\neligibility criteria will be invited to participate.\n\nPatients will be enrolled in cohorts consisting of 10 patients. Within each cohort\n8 patients will receive BOTOX and 2 patients will receive placebo. Sentinel dosing of the first 2 patients (1 BOTOX, 1 placebo) will occur at the commencement of cohort 1 and also for any subsequent cohort that escalates the dose. Following a 1-week observation period, providing there are no safety concerns with the sentinel patients, the remainder of the cohort will be enrolled.\nDose escalation will be based on independent Data Review Committee (DRC) recommendation, following review of 4 weeks of safety and efficacy data from the preceding cohort. The DRC may also recommend to repeat cohorts, de-escalate the dose, assess alternative doses, or stop the study.\n\nBased on the proposed doses it is anticipated that approximately 60 patients will be\nenrolled in the 6 planned cohorts. The actual number of patients entering the study will be determined by the number of cohorts (eg, escalations, repeat doses, de-escalations, or when the study is stopped). No more than 80 patients will be enrolled in the study.\n\nParticipation in the study will last at least 18 weeks with 6 to 7 clinic visits and 1 or 2 phone calls depending on whether the participant is in the sentinel or nonsentinel group.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0199
Date of REC Opinion
6 Aug 2013
REC opinion
Further Information Favourable Opinion