We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Safety and Efficacy Study of BOTOX® in Premature Ejaculation

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01917006
First Posted: August 6, 2013
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
This is a safety and efficacy study of BOTOX® (onabotulinumtoxinA) for the treatment of premature ejaculation in male patients.

Condition Intervention Phase
Premature Ejaculation Drug: OnabotulinumtoxinA Drug: Normal Saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures:
  • Change from Baseline in Average IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, and 12 ]
  • Change from Baseline in Geometric Mean IELT [ Time Frame: Baseline, Weeks 2, 4, 6, 8, and 10 ]

Enrollment: 59
Actual Study Start Date: August 27, 2013
Study Completion Date: August 15, 2017
Primary Completion Date: August 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OnabotulinumtoxinA Dose 1
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 2
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 3
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 4
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 5
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Experimental: OnabotulinumtoxinA Dose 6
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
Drug: OnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A
Placebo Comparator: Placebo
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Drug: Normal Saline
Placebo (normal saline) injected into specified muscle per protocol on Day 1.

Detailed Description:

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of BOTOX for the treatment of male patients with PE. Patients 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 IELT.

Patients will be enrolled in cohorts. Within the first 5 cohorts, 8 patients are to receive BOTOX and 2 patients to receive placebo. For cohort 6, 12 patients will receive BOTOX and 12 patients will receive placebo. Patients will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial BOTOX total dose in this dose escalation study will be 5 U and the maximum BOTOX total dose will be 100 U. Upon request and if eligible, patients in cohort 6, will have the option to receive a second injection of BOTOX (open label).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • Patient 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917006


  Show 23 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Daniel Radecki Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01917006     History of Changes
Other Study ID Numbers: 191622-133
2013-001650-94 ( EudraCT Number )
First Submitted: August 2, 2013
First Posted: August 6, 2013
Last Update Posted: September 20, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents