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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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