A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01917006
• Other study ID #: 191622-133
• Secondary ID: 2013-001650-94
• Status: Terminated
• Phase: Phase 2
• Start date: August 7, 2013
• Est. completion date: August 15, 2017

Study information

• Verified date: September 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: August 15, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
• Normal Saline
Placebo (normal saline) injected into specified muscle per protocol on Day 1.

Locations

Country	Name	City	State
United Kingdom	Celerion	Belfast
United Kingdom	King's College Hospital	London
United Kingdom	Queen Anne Street Medical Center	London
United Kingdom	St Mary's Hospital	London
United States	Connecticut Clinical Research Center	Middlebury	Connecticut
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Manhattan Medical Research	New York	New York
United States	San Diego Sexual Medicine	San Diego	California
United States	LA Biomedical Research Institute at Harbor-UCLA Medical Center	Torrance	California
United States	Center for Marital and Sexual Health of South Florida	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Average IELT	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
Secondary	Change From Baseline in Geometric Mean IELT	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

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