Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia
Status:
Unknown status
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
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
Phase:
N/A
Details
Lead Sponsor:
Dr. John A. Thiel Medical Professional Corporation