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Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia

NCT03427216 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-07

No results posted yet for this study

Summary

This study is a randomized, placebo controlled double blind cross over trial. Patients presenting with pelvic floor myalgia will be asked to complete a series of standardized questionnaires to assess their pain, quality of life and sexual function and satisfaction. They will be randomized to either a treatment group or placebo group and will use the supplied suppositories once daily for 2 months. They will then undergo a one month "washout" after which they will be placed in the cross over group for a second two months of treatment.

Primary outcome measure: change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment Secondary outcome measures: change in Female Sexual Function Index (FSFI), Patient Global Impression of Improvement (PGI-I), and Short Form Health Survey (SF-12) before and after treatment

Conditions

  • Pelvic Floor Dyssynergia

Interventions

DRUG

Baclofen/diazepam

Vaginal suppository placed once daily, patients will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weekly

DRUG

Vaginal placebo

Vaginal suppository placed once daily, patient will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weeky.

Sponsors & Collaborators

  • Dr. John A. Thiel Medical Professional Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-12-31
Completion
2018-12-31

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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 NCT03427216 on ClinicalTrials.gov