A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Phase 2

Terminated

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).

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Placebo	Normal Saline	Placebo (normal saline) injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 1	OnabotulinumtoxinA	OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 2	OnabotulinumtoxinA	OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
OnabotulinumtoxinA Dose 4	OnabotulinumtoxinA	OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 3	OnabotulinumtoxinA	OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 6	OnabotulinumtoxinA	OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 5	OnabotulinumtoxinA	OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)	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

Name	Time	Method
Change From Baseline in Geometric Mean IELT	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.
Change From Baseline in Average IELT	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.

Locations (10): Manhattan Medical Research
🇺🇸
New York, New York, United States
King's College Hospital
🇬🇧
London, United Kingdom
Celerion
🇬🇧
Belfast, United Kingdom
Queen Anne Street Medical Center
🇬🇧
London, United Kingdom
St Mary's Hospital
🇬🇧
London, United Kingdom
LA Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸
Torrance, California, United States
San Diego Sexual Medicine
🇺🇸
San Diego, California, United States
Center for Marital and Sexual Health of South Florida
🇺🇸
West Palm Beach, Florida, United States
Connecticut Clinical Research Center
🇺🇸
Middlebury, Connecticut, United States
Tulane University School of Medicine
🇺🇸
New Orleans, Louisiana, United States