Study Stopped
Strategic business decision was made to terminate the program. There were no safety concerns.
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
2 other identifiers
interventional
59
2 countries
10
Brief Summary
This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2013
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2013
CompletedFirst Posted
Study publicly available on registry
August 6, 2013
CompletedStudy Start
First participant enrolled
August 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2017
CompletedResults Posted
Study results publicly available
October 18, 2018
CompletedOctober 18, 2018
September 1, 2018
4 years
August 2, 2013
August 15, 2018
September 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Baseline (Day 1) to Week 12
Secondary Outcomes (2)
Change From Baseline in Average IELT
Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12
Change From Baseline in Geometric Mean IELT
Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10
Study Arms (7)
OnabotulinumtoxinA Dose 1
EXPERIMENTALOnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 2
EXPERIMENTALOnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
OnabotulinumtoxinA Dose 3
EXPERIMENTALOnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 4
EXPERIMENTALOnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 5
EXPERIMENTALOnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 6
EXPERIMENTALOnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
Placebo
PLACEBO COMPARATORPlacebo (normal saline) injected into specified muscle per protocol on Day 1.
Interventions
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (10)
San Diego Sexual Medicine
San Diego, California, 92120, United States
LA Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Connecticut Clinical Research Center
Middlebury, Connecticut, 06762, United States
Center for Marital and Sexual Health of South Florida
West Palm Beach, Florida, 33401, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Manhattan Medical Research
New York, New York, 10016, United States
Celerion
Belfast, BT9 6AD, United Kingdom
King's College Hospital
London, SE5 9RJ, United Kingdom
Queen Anne Street Medical Center
London, W1G 8HU, United Kingdom
St Mary's Hospital
London, W2 1NY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Daniel Radecki
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2013
First Posted
August 6, 2013
Study Start
August 7, 2013
Primary Completion
August 15, 2017
Study Completion
August 15, 2017
Last Updated
October 18, 2018
Results First Posted
October 18, 2018
Record last verified: 2018-09