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A Study Examining the Use of Vaginal Nifedipine With Pelvic Floor Physical Therapy for Levator Myalgia and Pelvic Pain

NCT01586286 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-05-22

No results posted yet for this study

Summary

The objective of this study is to perform a randomized controlled trial among female patients with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain, dysfunctional voiding, dyspareunia, and/ or obstructed defecation.

Conditions

  • Levator Ani Syndrome

Interventions

DRUG

Nifedipine

Nifedipine - 0.2% concentration in a lanolin base; administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area

DRUG

Placebo Ointment Base

Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Daniel Biller, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

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 NCT01586286 on ClinicalTrials.gov