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A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

NCT ID: NCT01917006

Last Updated: 2018-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-07

Study Completion Date

2017-08-15

Brief Summary

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

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Detailed Description

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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).

Conditions

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Premature Ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OnabotulinumtoxinA Dose 1

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

OnabotulinumtoxinA Dose 2

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

OnabotulinumtoxinA Dose 3

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

OnabotulinumtoxinA Dose 4

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

OnabotulinumtoxinA Dose 5

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

OnabotulinumtoxinA Dose 6

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Interventions

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OnabotulinumtoxinA

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

Intervention Type DRUG

Normal Saline

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

Intervention Type DRUG

Other Intervention Names

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BOTOX® Botulinum Toxin Type A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Radecki

Role: STUDY_DIRECTOR

Allergan

Locations

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San Diego Sexual Medicine

San Diego, California, United States

Site Status

LA Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

Connecticut Clinical Research Center

Middlebury, Connecticut, United States

Site Status

Center for Marital and Sexual Health of South Florida

West Palm Beach, Florida, United States

Site Status

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status

Manhattan Medical Research

New York, New York, United States

Site Status

Celerion

Belfast, , United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

Queen Anne Street Medical Center

London, , United Kingdom

Site Status

St Mary's Hospital

London, , United Kingdom

Site Status

Countries

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United States United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.allerganclinicaltrials.com

More Information

Other Identifiers

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2013-001650-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

191622-133

Identifier Type: -

Identifier Source: org_study_id

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