A Safety and Efficacy Study of BOTOX® in Premature Ejaculation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01917006
First received: August 2, 2013
Last updated: March 2, 2016
Last verified: March 2016
  Purpose
This is a safety and efficacy study of BOTOX® (onabotulinumtoxinA) for the treatment of premature ejaculation in male patients.

Condition Intervention Phase
Premature Ejaculation
Drug: OnabotulinumtoxinA
Drug: Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Average IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Geometric Mean IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, and 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OnabotulinumtoxinA Dose 1
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 2
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 3
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 4
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 5
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 6
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Placebo Comparator: Placebo
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Drug: Normal Saline
Placebo (normal saline) injected into specified muscle per protocol on Day 1.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • Patient 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917006

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com
Contact: PE Team infoUSA@peproblems.com

Locations
United States, California
LA Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
United States, Connecticut
Connecticut Clinical Research Center Recruiting
Middlebury, Connecticut, United States, 06762
United States, Florida
Center for Marital and Sexual Health of South Florida Recruiting
West Palm Beach, Florida, United States, 33401
United States, Louisiana
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
United States, New York
Manhattan Medical Research Recruiting
New York, New York, United States, 10016
United Kingdom
King's College Hospital Recruiting
Denmark Hill, London, United Kingdom, SE5 9RS
St Mary's Hospital Recruiting
Praed Street, London, United Kingdom, W2 1NY
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01917006     History of Changes
Other Study ID Numbers: 191622-133  2013-001650-94 
Study First Received: August 2, 2013
Last Updated: March 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Premature Ejaculation
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
IncobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2016