A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Study Identifier
191622-133
CT.gov Identifier
NCT01917006
EudraCT Identifier
2013-001650-94
EUCTIS ID
Not available
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Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Men's Health
    • Study Drug
  • OnabotulinumtoxinA
  • Normal Saline
    • Phase
    Phase 2
    Sex
    Male
    Age
    18 - 50 Years
    Inclusion and Exclusion 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

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    San Diego Sexual Medicine
    San Diego, California, United States, 92120
    Status
    Not applicable
    Location
    LA Biomedical Research Institute at Harbor-UCLA Medical Center
    Torrance, California, United States, 90502
    Status
    Not applicable
    Location
    Connecticut Clinical Research Center
    Middlebury, Connecticut, United States, 06762
    Status
    Not applicable
    Location
    Center for Marital and Sexual Health of South Florida
    West Palm Beach, Florida, United States, 33401
    Status
    Not applicable
    Location
    Tulane University School of Medicine
    New Orleans, Louisiana, United States, 70112
    Status
    Not applicable
    Location
    Manhattan Medical Research
    New York, New York, United States, 10016
    Status
    Not applicable
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