A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
Premature Ejaculation
About this trial
This is an interventional treatment trial for Premature Ejaculation
Eligibility 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
Sites / Locations
- San Diego Sexual Medicine
- LA Biomedical Research Institute at Harbor-UCLA Medical Center
- Connecticut Clinical Research Center
- Center for Marital and Sexual Health of South Florida
- Tulane University School of Medicine
- Manhattan Medical Research
- Celerion
- King's College Hospital
- Queen Anne Street Medical Center
- St Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
OnabotulinumtoxinA Dose 1
OnabotulinumtoxinA Dose 2
OnabotulinumtoxinA Dose 3
OnabotulinumtoxinA Dose 4
OnabotulinumtoxinA Dose 5
OnabotulinumtoxinA Dose 6
Placebo
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
Placebo (normal saline) injected into specified muscle per protocol on Day 1.