CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Botulinum toxin (BoNT) +1 moredrug
Likely dose
Botulinum toxin (BoNT) 100 Unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01553201
NCT01553201Phase 2Completed

The Effectiveness of Botulinum Toxin on Persistent Pelvic Pain in Women With Endometriosis

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Mar 14, 2012·Updated Jul 28, 2020

In Brief

A Phase 2 clinical trial evaluating Botulinum toxin (BoNT) and Placebo for Endometriosis and 3 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Background: \- Some women with endometriosis have chronic pelvic pain. This pain may be caused by spasms of the pelvic floor muscles. These spasms can be detected by an examination. Studies suggest that botulinum toxin can help treat problems caused by muscle spasms. Researchers want to see if botulinum toxin injections into the pelvic floor muscles can decrease pain and spasms in women with pelvic pain. Objectives: \- To see if botulinum toxin can relieve pain from pelvic floor spasm in women with pelvic pain. Eligibility: \- Women between 18 and 50 years of age with pain associated with pelvic muscle spasm and endometriosis. Pain must be persistent (lasting for at least 3 months). Design: * Participants will keep a pain diary and record their pain medication use for a month before the first visit. * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Participants will also answer questions about their pain levels and quality of life. * Participants will receive either botulinum toxin or a placebo (salt water) injection. The injection will be given into the pelvic floor muscles through the vaginal wall. Participants will take a muscle relaxant like Valium and have anesthetic cream put on the vaginal wall before the injection. * After the injection, participants will keep a pain diary for another month. * At a 1-month followup visit, participants will answer questions about their pain. If the pain has not improved, all participants may have a botulinum toxin injection (no placebo) into the pelvic floor muscles as before. * Participants will have followup visits for up to a year after the initial 1-month followup visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2012
Enrollment StartJul 30, 2014
Primary CompletionJul 31, 2018
Study CompletionJul 24, 2019
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.3 years ago

Interventions

Botulinum toxin (BoNT)drug

OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration

Placebodrug

Saline, 4cc, one time intramuscular administration