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Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia (BDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427216
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
John Thiel, Dr. John A. Thiel Medical Professional Corporation

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


Condition or disease Intervention/treatment Phase
Pelvic Floor Dyssynergia Drug: Baclofen/diazepam Drug: Vaginal placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Placebo Controlled Cross-over Trial of Baclofen and Diazepam Suppositories for the Management of Pelvic Floor Myalgia
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vaginal Baclofen/diazepam supp
Insert vaginal suppository once daily
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
Other Name: Lioresal

Placebo Comparator: Vaginal Placebo supp
Insert vaginal suppository once daily
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.
Other Name: suppository




Primary Outcome Measures :
  1. Change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment [ Time Frame: 5 months ]
    The scale ranges from 0 (no pain) to 10 (worst pain ever experienced)


Secondary Outcome Measures :
  1. Change in Female Sexual Function Index (FSFI) [ Time Frame: 5 months ]
    Self report measure of female sexual dysfunction

  2. Patient Global Impression of Improvement (PGI-I) [ Time Frame: 5 months ]
    Ranks patients overall feeling about health from 1 (very much better) to 7 (very much worse)

  3. Short form Health Survey (SF-12) [ Time Frame: 5 months ]
    Standardized self assessment tool to measure overall health status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   46XX women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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Responsible Party: John Thiel, Clinical Professor, Dr. John A. Thiel Medical Professional Corporation
ClinicalTrials.gov Identifier: NCT03427216    
Other Study ID Numbers: Jthiel
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only pooled data will be shared outside of the research team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myalgia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Diazepam
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents