A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

September 21, 2018 updated by: Allergan

An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 6AD
        • Celerion
      • London, United Kingdom, W2 1NY
        • St Mary's Hospital
      • London, United Kingdom, SE5 9RJ
        • King's College Hospital
      • London, United Kingdom, W1G 8HU
        • Queen Anne Street Medical Center
  • United States
    • California
      • San Diego, California, United States, 92120
        • San Diego Sexual Medicine
      • Torrance, California, United States, 90502
        • LA BioMedical Research Institute at Harbor-UCLA Medical Center
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Connecticut Clinical Research Center
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Center For Marital and Sexual Health of South Florida
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • New York
      • New York, New York, United States, 10016
        • Manhattan Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12
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.
Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Daniel Radecki, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2013

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-133
  • 2013-001650-94 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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