A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Premature Ejaculation

In brief

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

Key facts

Study ID

NCT01917006

Run by

Allergan

People needed

59

Starts

2013-08-07

Expected to finish

2017-08-15

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Diego Sexual Medicine — San Diego, California, United States
• LA Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Connecticut Clinical Research Center — Middlebury, Connecticut, United States
• Center for Marital and Sexual Health of South Florida — West Palm Beach, Florida, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• Manhattan Medical Research — New York, New York, United States
• Celerion — Belfast, United Kingdom
• King's College Hospital — London, United Kingdom
• Queen Anne Street Medical Center — London, United Kingdom
• St Mary's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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