A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Allergan

Status and phase: Terminated; Phase 2

Conditions: Premature Ejaculation

Treatments: Drug: Normal Saline; Drug: OnabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01917006

191622-133

2013-001650-94 (EudraCT Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 59 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

59 participants in 7 patient groups, including a placebo group

OnabotulinumtoxinA Dose 1

Experimental group

Description:

OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.

Treatment:

Drug: OnabotulinumtoxinA

OnabotulinumtoxinA Dose 2

Experimental group

Description:

OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.

Treatment:

Drug: OnabotulinumtoxinA

OnabotulinumtoxinA Dose 3

Experimental group

Description:

OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.

Treatment:

Drug: OnabotulinumtoxinA

OnabotulinumtoxinA Dose 4

Experimental group

Description:

OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.

Treatment:

Drug: OnabotulinumtoxinA

OnabotulinumtoxinA Dose 5

Experimental group

Description:

OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.

Treatment:

Drug: OnabotulinumtoxinA

OnabotulinumtoxinA Dose 6

Experimental group

Description:

OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.

Treatment:

Drug: OnabotulinumtoxinA

Placebo

Placebo Comparator group

Description:

Placebo (normal saline) injected into specified muscle per protocol on Day 1.

Treatment:

Drug: Normal Saline