Status:
TERMINATED
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
Lead Sponsor:
Allergan
Conditions:
Premature Ejaculation
Eligibility:
MALE
18-50 years
Phase:
PHASE2
Brief 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. Par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2017
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01917006
Start Date
August 7 2013
End Date
August 15 2017
Last Update
October 18 2018
Active Locations (10)
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1
San Diego Sexual Medicine
San Diego, California, United States, 92120
2
LA Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
3
Connecticut Clinical Research Center
Middlebury, Connecticut, United States, 06762
4
Center for Marital and Sexual Health of South Florida
West Palm Beach, Florida, United States, 33401