A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

• Status: Terminated
• Trial end date: 2017-08-15
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• History of premature ejaculation

• Stable monogamous sexual relationship with female partner for at least 6 months, and intends to continue with the same partner for the duration of the study

• Participant has ability to follow study instructions and complete study assessment tools

Exclusion Criteria:

• Premature ejaculation caused by medical or surgical issues, or is related to stress or other issues (eg, relationship problems)

• Pain with ejaculation

• Planned use of topical penile treatments (eg, anesthetics, herbal treatments) or penile injections during the study

• Prior genital, prostatic or lower urinary tract surgery (other than vasectomy or circumcision)

• Previous or current usage of botulinum toxin therapy of any serotype for any urological condition

• Use of botulinum toxin therapy of any serotype for any nonurological condition (eg, cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage during the study

• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis