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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

Tracking Information
First Submitted Date  ICMJE August 2, 2013
First Posted Date  ICMJE August 6, 2013
Results First Submitted Date  ICMJE August 15, 2018
Results First Posted Date  ICMJE October 18, 2018
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE August 7, 2013
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2013)
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Baseline, Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2013)
  • Change From Baseline in Average IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, and 12 ]
  • Change From Baseline in Geometric Mean IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, and 10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
Official Title  ICMJE An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
Brief Summary This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Premature Ejaculation
Intervention  ICMJE
  • Drug: OnabotulinumtoxinA
    OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
    Other Names:
    • BOTOX®
    • Botulinum Toxin Type A
  • Drug: Normal Saline
    Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Study Arms  ICMJE
  • Experimental: OnabotulinumtoxinA Dose 1
    OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
    Intervention: Drug: OnabotulinumtoxinA
  • 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.
    Intervention: Drug: OnabotulinumtoxinA
  • Experimental: OnabotulinumtoxinA Dose 3
    OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
    Intervention: Drug: OnabotulinumtoxinA
  • Experimental: OnabotulinumtoxinA Dose 4
    OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
    Intervention: Drug: OnabotulinumtoxinA
  • Experimental: OnabotulinumtoxinA Dose 5
    OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
    Intervention: Drug: OnabotulinumtoxinA
  • Experimental: OnabotulinumtoxinA Dose 6
    OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
    Intervention: Drug: OnabotulinumtoxinA
  • Placebo Comparator: Placebo
    Placebo (normal saline) injected into specified muscle per protocol on Day 1.
    Intervention: Drug: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2017)
59
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2013)
60
Actual Study Completion Date  ICMJE August 15, 2017
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01917006
Other Study ID Numbers  ICMJE 191622-133
2013-001650-94 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Radecki Allergan
PRS Account Allergan
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP