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A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

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ClinicalTrials.gov Identifier: NCT01917006
Recruitment Status : Terminated (Strategic business decision was made to terminate the program. There were no safety concerns.)
First Posted : August 6, 2013
Results First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Premature Ejaculation Drug: OnabotulinumtoxinA Drug: Normal Saline Phase 2

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. Participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. Partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (IELT). Participants will be enrolled in cohorts. Within the first 5 cohorts, 8 participants are to receive OnabotulinumtoxinA and 2 participants to receive placebo. For cohort 6, 12 participants will receive OnabotulinumtoxinA and 12 participants will receive placebo. Participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial OnabotulinumtoxinA total dose in this dose escalation study will be 5 U and the maximum OnabotulinumtoxinA total dose will be 100 U. Upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of OnabotulinumtoxinA (Open-label).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
Actual Study Start Date : August 7, 2013
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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. Participants were eligible for another treatment after 12 weeks.
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.




Primary Outcome Measures :
  1. Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Baseline (Day 1) to Week 12 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Average IELT [ Time Frame: Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12 ]
    IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.

  2. Change From Baseline in Geometric Mean IELT [ Time Frame: Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10 ]
    IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the 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 SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917006


Locations
United States, California
San Diego Sexual Medicine
San Diego, California, United States, 92120
LA Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Connecticut
Connecticut Clinical Research Center
Middlebury, Connecticut, United States, 06762
United States, Florida
Center for Marital and Sexual Health of South Florida
West Palm Beach, Florida, United States, 33401
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, New York
Manhattan Medical Research
New York, New York, United States, 10016
United Kingdom
Celerion
Belfast, United Kingdom, BT9 6AD
King's College Hospital
London, United Kingdom, SE5 9RJ
Queen Anne Street Medical Center
London, United Kingdom, W1G 8HU
St Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Allergan
Investigators
Study Director: Daniel Radecki Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] July 15, 2016
Statistical Analysis Plan  [PDF] November 8, 2016


Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01917006     History of Changes
Other Study ID Numbers: 191622-133
2013-001650-94 ( EudraCT Number )
First Posted: August 6, 2013    Key Record Dates
Results First Posted: October 18, 2018
Last Update Posted: October 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
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
onabotulinumtoxinA
abobotulinumtoxinA
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