xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968937</url>
    </required_header>
    <id_info>
      <org_study_id>22.1000</org_study_id>
      <nct_id>NCT05968937</nct_id>
    </id_info>
    <brief_title>Vaginal Baclofen Suppositories in Chronic Pelvic Pain</brief_title>
    <official_title>Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Louisville</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Louisville</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms&#xD;
        of Chronic Pelvic Pain (CPP).&#xD;
  &#xD;
        Participants in this study will take four short questionnaires prior to being randomized.&#xD;
        Randomization is like flipping a coin; participants have an equal likelihood of being&#xD;
        randomized to the treatment group (vaginal baclofen suppositories) or placebo group (vaginal&#xD;
        suppository without baclofen ingredient). Participants will take their assigned treatment&#xD;
        nightly for 8 weeks. Follow up visits will be at the 4 and 8 week time frames, when&#xD;
        questionnaires will again be completed. Participants may receive additional treatments for&#xD;
        CPP during the course of the study. After 8 weeks Participants will be offered a prescription&#xD;
        for baclofen suppositories and the study drug will be stopped. Follow up on patient symptoms&#xD;
        with questionnaires will again occur at 12 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Design/Methodology&#xD;
  &#xD;
        This is a single center, double-blinded, placebo-controlled, randomized trial. Women will be&#xD;
        recruited from a subspecialty clinic at the University of Louisville and be eligible for&#xD;
        participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of&#xD;
        18-65 years old. Eligible, consenting participants will undergo randomization with equal&#xD;
        probability of assignment to one of the two groups:&#xD;
  &#xD;
          1. Baclofen 20mg vaginal suppository daily per vagina and&#xD;
  &#xD;
          2. placebo.&#xD;
  &#xD;
        Participants will be blinded to study allocation. Baclofen or placebo suppositories will be&#xD;
        continued to 8 weeks, at which time all participants will be offered a baclofen suppository&#xD;
        prescription. Patients will then follow up at the 12 week mark and whether they continued&#xD;
        baclofen suppositories and pill count will be recorded in addition to the below&#xD;
        questionnaires.&#xD;
  &#xD;
        Clinical outcomes and questionnaires will be assessed at baseline and after 4, 8, and 12&#xD;
        weeks of treatment. Participants will be randomized with a stratified block randomization&#xD;
        scheme (with a random block size of 4, 6, and 8 participants).&#xD;
  &#xD;
        Participants will be required to come in for at least 1 visit at 8 weeks to assess pelvic&#xD;
        muscle dysfunction and perform pill count.&#xD;
  &#xD;
        We hypothesize a significant change in PROMIS Pain Interference score, patient satisfaction,&#xD;
        PROMIS global health scores, and PROMIS sexual function scores for patients assigned to the&#xD;
        baclofen treatment arm.&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
          -  Women ages 18-65 years old&#xD;
  &#xD;
          -  Women are not sexually active, sexually active with same sex partners or are on&#xD;
             effective contraception&#xD;
  &#xD;
          -  Diagnosed with Chronic Pelvic Pain&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
          -  Gross hematuria&#xD;
  &#xD;
          -  Currently pregnant or breastfeeding&#xD;
  &#xD;
          -  Unable to speak and read English&#xD;
  &#xD;
          -  History of allergic reaction to baclofen tablet&#xD;
  &#xD;
          -  History of allergic reaction to components of placebo (coconut oil)&#xD;
  &#xD;
          -  History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a single-center, double-blinded, placebo-controlled, randomized trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Randomization will be carried out by a computer-based algorithm that will generate study/subject number. This number will correspond with treatment and communicate to The Louisville compounding pharmacy the appropriate drug to distribute without the unblinding of patient or provider. with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Randomization will be stratified based on pelvic muscle tenderness on exam - stratifying by 0-5/10 and 6-10/10 tenderness of pelvic floor musculature on physical exam</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Visual analogue Score (VAS) 1-100 for pain</measure>
      <time_frame>at 8 weeks of suppository use</time_frame>
      <description>VAS is a 1-100mm scale with lower scores indicating less pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score</measure>
      <time_frame>at baseline and at 4, 8 and 12 weeks</time_frame>
      <description>Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference score is a 40-200 point scale with lower values indicating lower pain interference with quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pelvic floor impact questionnaire</measure>
      <time_frame>at baseline and at 4, 8, and 12 week follow up</time_frame>
      <description>pelvic floor impact questionnaire is a 0-63 point composite scale consisting of questions concerning bladder/urinary, bowel/rectal, and vaginal/pelvic symptoms with higher values indicating higher symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pelvic floor disability index (PFDI) questionnaire</measure>
      <time_frame>at baseline and at 4, 8, and 12 week follow up</time_frame>
      <description>the pelvic floor disability index (PFDI) questionnaire is a composite questionnaire on a 0-80 point scale containing questions regarding pelvic organ prolapse, colorectal/anal distress, and urinary distress questions with higher scores indicating higher symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue Score (VAS) 1-100 for pain</measure>
      <time_frame>at baseline and at 4 and 12 week follow up</time_frame>
      <description>VAS is a 1-100mm scale with lower scores indicating less pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>O'Leary Sant questionnaire</measure>
      <time_frame>at baseline and at 4, 8, and 12 week follow up</time_frame>
      <description>O'Leary Sant questionnaire is a 0 to 37 point score with higher points indicating increased symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) global health score</measure>
      <time_frame>at baseline and at 4, 8, and 12 week follow up</time_frame>
      <description>Patient-Reported Outcomes Measurement Information System (PROMIS) global health score is a 9-45 point scale with higher scores indicating better overall health and quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Satisfaction</measure>
      <time_frame>at 4, 8, and 12 week follow up</time_frame>
      <description>Overall Satisfaction is a yes/no questionnaire with if &quot;yes&quot; is selected one selects choices from &quot;somewhat&quot; to &quot;quite a bit&quot; in satisfaction. &quot;quite a bit&quot; would indicate greater satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score</measure>
      <time_frame>at 0, 4, 8, and 12 week follow up</time_frame>
      <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score is a 9-36 point score with higher scores indicating higher bother related to sexual function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of other treatments for chronic pelvic pain during the trial period</measure>
      <time_frame>at 4, 8, and 12 week follow up</time_frame>
      <description>Number of other treatments for chronic pelvic pain during the trial period to determine if results are clouded by other, appropriate, evidence based treatments received for chronic pelvic pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pill Count</measure>
      <time_frame>at 4, 8, and 12 week follow up</time_frame>
      <description>Pill Count to determine how many doses of the study medication have been missed</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Chronic Pelvic Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>Vaginal baclofen suppository</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Baclofen 20mg in Supposibase F vaginal suppository daily per vagina</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vaginal placebo suppository</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Supposibase F vaginal suppository daily per vagina</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>20 mg baclofen vaginal suppository daily per vagina</intervention_name>
      <description>20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy</description>
      <arm_group_label>Vaginal baclofen suppository</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Vaginal suppository composed of Supposibase F daily per vagina</description>
      <arm_group_label>Vaginal placebo suppository</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women ages 18-65 years old&#xD;
  &#xD;
            -  Women are not sexually active, sexually active with same sex partners or are on&#xD;
               effective contraception&#xD;
  &#xD;
            -  Diagnosed with Chronic Pelvic Pain&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Gross hematuria&#xD;
  &#xD;
            -  Currently pregnant or breastfeeding&#xD;
  &#xD;
            -  Unable to speak and read English&#xD;
  &#xD;
            -  History of allergic reaction to baclofen tablet&#xD;
  &#xD;
            -  History of allergic reaction to components of placebo (coconut oil)&#xD;
  &#xD;
            -  History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rodger Rothenberger, MD</last_name>
      <phone>5025887663</phone>
      <email>rwroth03@louisville.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ankita Gupta, MD</last_name>
      <phone>5025887663</phone>
      <email>ankita.gupta@louisville.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Doggweiler R, Whitmore KE, Meijlink JM, Drake MJ, Frawley H, Nordling J, Hanno P, Fraser MO, Homma Y, Garrido G, Gomes MJ, Elneil S, van de Merwe JP, Lin ATL, Tomoe H. A standard for terminology in chronic pelvic pain syndromes: A report from the chronic pelvic pain working group of the international continence society. Neurourol Urodyn. 2017 Apr;36(4):984-1008. doi: 10.1002/nau.23072. Epub 2016 Aug 26.</citation>
      <PMID>27564065</PMID>
    </reference>
    <reference>
      <citation>Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.</citation>
      <PMID>34128995</PMID>
    </reference>
    <reference>
      <citation>Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.</citation>
      <PMID>32080051</PMID>
    </reference>
    <reference>
      <citation>Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.</citation>
      <PMID>8598948</PMID>
    </reference>
    <reference>
      <citation>Brawn J, Morotti M, Zondervan KT, Becker CM, Vincent K. Central changes associated with chronic pelvic pain and endometriosis. Hum Reprod Update. 2014 Sep-Oct;20(5):737-47. doi: 10.1093/humupd/dmu025. Epub 2014 Jun 11.</citation>
      <PMID>24920437</PMID>
    </reference>
    <reference>
      <citation>Shafrir AL, Martel E, Missmer SA, Clauw DJ, Harte SE, As-Sanie S, Sieberg CB. Pelvic floor, abdominal and uterine tenderness in relation to pressure pain sensitivity among women with endometriosis and chronic pelvic pain. Eur J Obstet Gynecol Reprod Biol. 2021 Sep;264:247-253. doi: 10.1016/j.ejogrb.2021.07.029. Epub 2021 Jul 22.</citation>
      <PMID>34340095</PMID>
    </reference>
    <reference>
      <citation>Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. doi: 10.1002/nau.20144. No abstract available.</citation>
      <PMID>15977259</PMID>
    </reference>
    <reference>
      <citation>Moldwin RM, Fariello JY. Myofascial trigger points of the pelvic floor: associations with urological pain syndromes and treatment strategies including injection therapy. Curr Urol Rep. 2013 Oct;14(5):409-17. doi: 10.1007/s11934-013-0360-7.</citation>
      <PMID>23943509</PMID>
    </reference>
    <reference>
      <citation>Frederice CP, Brito LGO, Pereira GMV, Lunardi ALB, Juliato CRT. Interventional treatment for myofascial pelvic floor pain in women: systematic review with meta-analysis. Int Urogynecol J. 2021 May;32(5):1087-1096. doi: 10.1007/s00192-021-04725-x. Epub 2021 Feb 27.</citation>
      <PMID>33640993</PMID>
    </reference>
    <reference>
      <citation>Stone RH, Abousaud M, Abousaud A, Kobak W. A Systematic Review of Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S110-S120. doi: 10.1002/jcph.1775.</citation>
      <PMID>33274514</PMID>
    </reference>
    <reference>
      <citation>Juergens S. Alprazolam and diazepam: addiction potential. J Subst Abuse Treat. 1991;8(1-2):43-51. doi: 10.1016/0740-5472(91)90026-7.</citation>
      <PMID>2051498</PMID>
    </reference>
    <reference>
      <citation>Das S, Palappalllil DS, Purushothaman ST, Rajan V. An Unusual Case of Baclofen Abuse. Indian J Psychol Med. 2016 Sep-Oct;38(5):475-476. doi: 10.4103/0253-7176.191383.</citation>
      <PMID>27833235</PMID>
    </reference>
    <reference>
      <citation>Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.</citation>
      <PMID>30527941</PMID>
    </reference>
    <reference>
      <citation>Amtmann D, Kim J, Chung H, Askew RL, Park R, Cook KF. Minimally important differences for Patient Reported Outcomes Measurement Information System pain interference for individuals with back pain. J Pain Res. 2016 Apr 27;9:251-5. doi: 10.2147/JPR.S93391. eCollection 2016.</citation>
      <PMID>27175093</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Louisville</investigator_affiliation>
      <investigator_full_name>Ankita Gupta</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Baclofen</keyword>
    <keyword>vaginal suppository</keyword>
    <keyword>pelvic floor muscle dysfunction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pelvic Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Baclofen</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This study information will be sourced from the subjects. Identifying information and data collected during this study will be kept secure and confidential. For confidentiality, only research team members will have access to the study information in the database. Subjects will be assigned a unique study ID that will be used on all case report forms and database reporting. The database that will be used is REDCap which is HIPPA (Health Insurance Portability and Accountability Act of 1996) compliant, encrypted, and password protected. Any hard copies will be maintained in a locked cabinet in a locked office by a member of the research team.&#xD;
  The research personnel in this study are CITI and HIPAA trained. If new research personnel are added, an amendment will be submitted to and approved by the IRB before being allowed to participate in the study</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968937
  org study id: 22.1000
  nct id: NCT05968937
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms
        of Chronic Pelvic Pain (CPP).
  
        Participants in this study will take four short questionnaires prior to being randomized.
        Randomization is like flipping a coin; participants have an equal likelihood of being
        randomized to the treatment group (vaginal baclofen suppositories) or placebo group (vaginal
        suppository without baclofen ingredient). Participants will take their assigned treatment
        nightly for 8 weeks. Follow up visits will be at the 4 and 8 week time frames, when
        questionnaires will again be completed. Participants may receive additional treatments for
        CPP during the course of the study. After 8 weeks Participants will be offered a prescription
        for baclofen suppositories and the study drug will be stopped. Follow up on patient symptoms
        with questionnaires will again occur at 12 weeks.
  Study Design/Methodology
  
        This is a single center, double-blinded, placebo-controlled, randomized trial. Women will be
        recruited from a subspecialty clinic at the University of Louisville and be eligible for
        participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of
        18-65 years old. Eligible, consenting participants will undergo randomization with equal
        probability of assignment to one of the two groups:
  
          1. Baclofen 20mg vaginal suppository daily per vagina and
  
          2. placebo.
  
        Participants will be blinded to study allocation. Baclofen or placebo suppositories will be
        continued to 8 weeks, at which time all participants will be offered a baclofen suppository
        prescription. Patients will then follow up at the 12 week mark and whether they continued
        baclofen suppositories and pill count will be recorded in addition to the below
        questionnaires.
  
        Clinical outcomes and questionnaires will be assessed at baseline and after 4, 8, and 12
        weeks of treatment. Participants will be randomized with a stratified block randomization
        scheme (with a random block size of 4, 6, and 8 participants).
  
        Participants will be required to come in for at least 1 visit at 8 weeks to assess pelvic
        muscle dysfunction and perform pill count.
  
        We hypothesize a significant change in PROMIS Pain Interference score, patient satisfaction,
        PROMIS global health scores, and PROMIS sexual function scores for patients assigned to the
        baclofen treatment arm.
  
        Inclusion Criteria:
  
          -  Women ages 18-65 years old
  
          -  Women are not sexually active, sexually active with same sex partners or are on
             effective contraception
  
          -  Diagnosed with Chronic Pelvic Pain
  
        Exclusion Criteria:
  
          -  Gross hematuria
  
          -  Currently pregnant or breastfeeding
  
          -  Unable to speak and read English
  
          -  History of allergic reaction to baclofen tablet
  
          -  History of allergic reaction to components of placebo (coconut oil)
  
          -  History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a single-center, double-blinded, placebo-controlled, randomized trial.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Randomization will be carried out by a computer-based algorithm that will generate study/subject number. This number will correspond with treatment and communicate to The Louisville compounding pharmacy the appropriate drug to distribute without the unblinding of patient or provider. with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Randomization will be stratified based on pelvic muscle tenderness on exam - stratifying by 0-5/10 and 6-10/10 tenderness of pelvic floor musculature on physical exam
  measure: Visual analogue Score (VAS) 1-100 for pain
  time frame: at 8 weeks of suppository use
  description: VAS is a 1-100mm scale with lower scores indicating less pain
  measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
  time frame: at baseline and at 4, 8 and 12 weeks
  description: Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference score is a 40-200 point scale with lower values indicating lower pain interference with quality of life
  measure: Pelvic floor impact questionnaire
  time frame: at baseline and at 4, 8, and 12 week follow up
  description: pelvic floor impact questionnaire is a 0-63 point composite scale consisting of questions concerning bladder/urinary, bowel/rectal, and vaginal/pelvic symptoms with higher values indicating higher symptoms
  measure: Pelvic floor disability index (PFDI) questionnaire
  time frame: at baseline and at 4, 8, and 12 week follow up
  description: the pelvic floor disability index (PFDI) questionnaire is a composite questionnaire on a 0-80 point scale containing questions regarding pelvic organ prolapse, colorectal/anal distress, and urinary distress questions with higher scores indicating higher symptoms
  measure: Visual analogue Score (VAS) 1-100 for pain
  time frame: at baseline and at 4 and 12 week follow up
  description: VAS is a 1-100mm scale with lower scores indicating less pain
  measure: O'Leary Sant questionnaire
  time frame: at baseline and at 4, 8, and 12 week follow up
  description: O'Leary Sant questionnaire is a 0 to 37 point score with higher points indicating increased symptoms
  measure: Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
  time frame: at baseline and at 4, 8, and 12 week follow up
  description: Patient-Reported Outcomes Measurement Information System (PROMIS) global health score is a 9-45 point scale with higher scores indicating better overall health and quality of life
  measure: Overall Satisfaction
  time frame: at 4, 8, and 12 week follow up
  description: Overall Satisfaction is a yes/no questionnaire with if "yes" is selected one selects choices from "somewhat" to "quite a bit" in satisfaction. "quite a bit" would indicate greater satisfaction.
  measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score
  time frame: at 0, 4, 8, and 12 week follow up
  description: Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score is a 9-36 point score with higher scores indicating higher bother related to sexual function
  measure: Number of other treatments for chronic pelvic pain during the trial period
  time frame: at 4, 8, and 12 week follow up
  description: Number of other treatments for chronic pelvic pain during the trial period to determine if results are clouded by other, appropriate, evidence based treatments received for chronic pelvic pain.
  measure: Pill Count
  time frame: at 4, 8, and 12 week follow up
  description: Pill Count to determine how many doses of the study medication have been missed
  arm group label: Vaginal baclofen suppository
  arm group type: Active Comparator
  description: Baclofen 20mg in Supposibase F vaginal suppository daily per vagina
  arm group label: Vaginal placebo suppository
  arm group type: Placebo Comparator
  description: Supposibase F vaginal suppository daily per vagina
  intervention type: Drug
  intervention name: 20 mg baclofen vaginal suppository daily per vagina
  description: 20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy
  arm group label: Vaginal baclofen suppository
  intervention type: Drug
  intervention name: Placebo
  description: Vaginal suppository composed of Supposibase F daily per vagina
  arm group label: Vaginal placebo suppository
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rodger Rothenberger, MD
  phone: 5025887663
  email: rwroth03@louisville.edu
  last name: Ankita Gupta, MD
  phone: 5025887663
  email: ankita.gupta@louisville.edu
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  PMID: 27564065
  citation: Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.
  PMID: 34128995
  citation: Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.
  PMID: 32080051
  citation: Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
  PMID: 8598948
  citation: Brawn J, Morotti M, Zondervan KT, Becker CM, Vincent K. Central changes associated with chronic pelvic pain and endometriosis. Hum Reprod Update. 2014 Sep-Oct;20(5):737-47. doi: 10.1093/humupd/dmu025. Epub 2014 Jun 11.
  PMID: 24920437
  citation: Shafrir AL, Martel E, Missmer SA, Clauw DJ, Harte SE, As-Sanie S, Sieberg CB. Pelvic floor, abdominal and uterine tenderness in relation to pressure pain sensitivity among women with endometriosis and chronic pelvic pain. Eur J Obstet Gynecol Reprod Biol. 2021 Sep;264:247-253. doi: 10.1016/j.ejogrb.2021.07.029. Epub 2021 Jul 22.
  PMID: 34340095
  citation: Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. doi: 10.1002/nau.20144. No abstract available.
  PMID: 15977259
  citation: Moldwin RM, Fariello JY. Myofascial trigger points of the pelvic floor: associations with urological pain syndromes and treatment strategies including injection therapy. Curr Urol Rep. 2013 Oct;14(5):409-17. doi: 10.1007/s11934-013-0360-7.
  PMID: 23943509
  citation: Frederice CP, Brito LGO, Pereira GMV, Lunardi ALB, Juliato CRT. Interventional treatment for myofascial pelvic floor pain in women: systematic review with meta-analysis. Int Urogynecol J. 2021 May;32(5):1087-1096. doi: 10.1007/s00192-021-04725-x. Epub 2021 Feb 27.
  PMID: 33640993
  citation: Stone RH, Abousaud M, Abousaud A, Kobak W. A Systematic Review of Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S110-S120. doi: 10.1002/jcph.1775.
  PMID: 33274514
  citation: Juergens S. Alprazolam and diazepam: addiction potential. J Subst Abuse Treat. 1991;8(1-2):43-51. doi: 10.1016/0740-5472(91)90026-7.
  PMID: 2051498
  citation: Das S, Palappalllil DS, Purushothaman ST, Rajan V. An Unusual Case of Baclofen Abuse. Indian J Psychol Med. 2016 Sep-Oct;38(5):475-476. doi: 10.4103/0253-7176.191383.
  PMID: 27833235
  citation: Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.
  PMID: 30527941
  citation: Amtmann D, Kim J, Chung H, Askew RL, Park R, Cook KF. Minimally important differences for Patient Reported Outcomes Measurement Information System pain interference for individuals with back pain. J Pain Res. 2016 Apr 27;9:251-5. doi: 10.2147/JPR.S93391. eCollection 2016.
  PMID: 27175093
  responsible party type: Principal Investigator
  investigator affiliation: University of Louisville
  investigator full name: Ankita Gupta
  investigator title: Principal Investigator
  mesh term: Pelvic Pain
  mesh term: Baclofen
  sharing ipd: No
  ipd description: This study information will be sourced from the subjects. Identifying information and data collected during this study will be kept secure and confidential. For confidentiality, only research team members will have access to the study information in the database. Subjects will be assigned a unique study ID that will be used on all case report forms and database reporting. The database that will be used is REDCap which is HIPPA (Health Insurance Portability and Accountability Act of 1996) compliant, encrypted, and password protected. Any hard copies will be maintained in a locked cabinet in a locked office by a member of the research team.
  The research personnel in this study are CITI and HIPAA trained. If new research personnel are added, an amendment will be submitted to and approved by the IRB before being allowed to participate in the study