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Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain

NCT02173405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-10

No results posted yet for this study

Summary

This research study because is looking at woman with symptoms of chronic pelvic pain caused by short, tight, and tender pelvic floor muscles (Myofascial Pelvic Pain syndrome). The purpose of this study is to determine whether or not injections with onabotulinumtoxinA (Botox) improve symptoms of pain and tenderness. The drug being studied, Botox is FDA approved for other uses. However, Botox is not FDA approved for the use in myofascial pelvic pain (MPP). Therefore, Botox is considered experimental or research in this study.

Conditions

  • Myofascial Pain Syndromes
  • Myofascial Trigger Point Pain
  • Trigger Point Pain, Myofascial

Interventions

DRUG

OnabotulinumtoxinA

comparison of OnabotulinumtoxinA with placebo

DRUG

Placebo

comparison of placebo with investigational drug OnabotulinumtoxinA

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Sangetta Mahajan, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2015-09-01
Completion
2016-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02173405 on ClinicalTrials.gov