Clinical trial NCT01917006: A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
Official title: An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Premature Ejaculation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
timeFrame: Baseline (Day 1) to Week 12
Secondary outcomes:
measure: Change From Baseline in Average IELT
timeFrame: Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12
measure: Change From Baseline in Geometric Mean IELT
timeFrame: Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Torrance
country: United States
facility: LA Biomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: West Palm Beach
country: United States
facility: Center for Marital and Sexual Health of South Florida
state: Florida
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Belfast
country: United Kingdom
facility: Celerion
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Queen Anne Street Medical Center
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: Allergan
name: Daniel Radecki
role: STUDY_DIRECTOR
References: