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NCT01553201 · ClinicalTrials.gov registry record · Phase 1
Botulinum Toxin for Pelvic Pain in Women With Endometriosis
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01553201 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants.
The verdict
NCT01553201, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Botulinum toxin (BoNT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-07-30 |
| Est. Completion | 2019-07-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01553201
The ClinicalTrials.gov registry entry for NCT01553201 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01553201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01553201 about?
NCT01553201 is a clinical study titled "Botulinum Toxin for Pelvic Pain in Women With Endometriosis". 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 botu...
What is the current status of trial NCT01553201?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-07-30. Estimated completion is 2019-07-24.
What interventions are being tested in trial NCT01553201?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin (BoNT) (DRUG).
Who is sponsoring clinical trial NCT01553201?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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