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A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

NCT01917006 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-10-18

Study results available
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Summary

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

Conditions

  • Premature Ejaculation

Interventions

DRUG

OnabotulinumtoxinA

OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.

DRUG

Normal Saline

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Daniel Radecki · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-07
Primary Completion
2017-08-15
Completion
2017-08-15
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917006 on ClinicalTrials.gov