Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia

NCT03427216 | Unknown

• 1 other identifier: Jthiel
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment

  The scale ranges from 0 (no pain) to 10 (worst pain ever experienced)

  5 months

Secondary Outcomes (3)

• Change in Female Sexual Function Index (FSFI)

  5 months

• Patient Global Impression of Improvement (PGI-I)

  5 months

• Short form Health Survey (SF-12)

  5 months

Study Arms (2)

Vaginal Baclofen/diazepam supp

ACTIVE COMPARATOR

Insert vaginal suppository once daily

Drug: Baclofen/diazepam

Vaginal Placebo supp

PLACEBO COMPARATOR

Insert vaginal suppository once daily

Drug: Vaginal placebo

Interventions

Baclofen/diazepam DRUG

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

Also known as: Lioresal

Vaginal Baclofen/diazepam supp

Vaginal placebo DRUG

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.

Also known as: suppository

Vaginal Placebo supp

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: 46XX women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with significant pelvic floor dyssynergia and pain during sexual activity.

You may not qualify if:

• Decide you do not wish to participate
• Are pregnant
• Have active pelvic inflammatory disease
• Have an active sexually transmitted infection (STI)
• Have a known or suspected cancer of the genital tract
• Have untreated or unevaluated changes in your Pap smear
• Are not currently sexually active
• Have an allergy to either baclofen or valium
• Are unable to complete the necessary study questionnaires

Sponsors & Collaborators

• Dr. John A. Thiel Medical Professional Corporation: lead

MeSH Terms

Interventions

Baclofen; Diazepam; Suppositories

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 9, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 7, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share