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/NCT06028009</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00006805</org_study_id>
      <nct_id>NCT06028009</nct_id>
    </id_info>
    <brief_title>PRP Injections for Genitourinary Syndrome of Menopause</brief_title>
    <official_title>Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medstar Health Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medstar Health Research Institute</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the&#xD;
        supernatant resulting in a solution with high concentration of platelets. Injection of PRP&#xD;
        stimulates cell growth and can has been proven safe and effective for uses in orthopedics,&#xD;
        dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a&#xD;
        therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has&#xD;
        been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to&#xD;
        determine if PRP injections into the anterior vaginal wall improve sexual functioning in&#xD;
        women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal&#xD;
        dryness/irritation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Female Sexual Function Index</measure>
      <time_frame>Assessed at baseline and at 6 weeks and 6 months post-procedure</time_frame>
      <description>Validated questionnaire to assess domains of sexual function</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Improvement (PGI-I)</measure>
      <time_frame>Assessed at 6 weeks and 6 months post-intervention</time_frame>
      <description>Single item questionnaire evaluating improvement in vaginal dryness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analog scale for vaginal dryness (VAS)</measure>
      <time_frame>Assessed at 6 weeks and 6 months post-intervention</time_frame>
      <description>Visual analog scale for vaginal dryness (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urinary Distress Inventory (short form) (UDI-6)</measure>
      <time_frame>Assessed at baseline and 6 weeks/6 months post-intervention</time_frame>
      <description>6 item questionnaire assessing urinary symptoms</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>PRP</condition>
    <condition>Sexual Function Disturbances</condition>
    <condition>Genitourinary Syndrome of Menopause</condition>
    <condition>Postmenopausal Symptoms</condition>
    <condition>Vaginal Atrophy</condition>
    <arm_group>
      <arm_group_label>Platelet-rich plasma injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>0.9% saline injection</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Injection of platelet-rich plasma</intervention_name>
      <description>Injection of autologous platelet-rich plasma into anterior vaginal wall</description>
      <arm_group_label>Platelet-rich plasma injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Injection of saline</intervention_name>
      <description>Injection of sterile normal saline into anterior vaginal wall</description>
      <arm_group_label>0.9% saline injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women (assigned female at birth) at least 18 years old with a clinical diagnosis of&#xD;
               GSM&#xD;
  &#xD;
            -  Sexually active with at least one episode of sexual activity per week in the preceding&#xD;
               4 weeks defined as follows: Partnered or solo penetrative or non-penetrative&#xD;
               stimulation of the clitoris or vagina&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Willingness and able to comply with the study requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Symptomatic pelvic organ prolapse protruding beyond the hymen)&#xD;
  &#xD;
            -  History of prior vaginal mesh or midurethral mesh sling surgery&#xD;
  &#xD;
            -  History of pelvic radiation or genital tract malignancy&#xD;
  &#xD;
            -  Current symptomatic pelvic organ prolapse (stage II or greater)&#xD;
  &#xD;
            -  Active vulvar dermatoses or genitourinary infection&#xD;
  &#xD;
            -  Unable to hold anticoagulation&#xD;
  &#xD;
            -  Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of&#xD;
               participation&#xD;
  &#xD;
            -  Pregnancy or pre-menopausal status&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Neha G Gaddam, M.D.</last_name>
      <phone>8328650244</phone>
      <email>neha.g.gaddam@medstar.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Neha G Gaddam, M.D.</last_name>
      <email>gaddam.ng@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06028009
  org study id: STUDY00006805
  nct id: NCT06028009
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the
        supernatant resulting in a solution with high concentration of platelets. Injection of PRP
        stimulates cell growth and can has been proven safe and effective for uses in orthopedics,
        dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a
        therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has
        been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to
        determine if PRP injections into the anterior vaginal wall improve sexual functioning in
        women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal
        dryness/irritation.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Female Sexual Function Index
  time frame: Assessed at baseline and at 6 weeks and 6 months post-procedure
  description: Validated questionnaire to assess domains of sexual function
  measure: Patient Global Impression of Improvement (PGI-I)
  time frame: Assessed at 6 weeks and 6 months post-intervention
  description: Single item questionnaire evaluating improvement in vaginal dryness
  measure: Visual analog scale for vaginal dryness (VAS)
  time frame: Assessed at 6 weeks and 6 months post-intervention
  description: Visual analog scale for vaginal dryness (VAS)
  measure: Urinary Distress Inventory (short form) (UDI-6)
  time frame: Assessed at baseline and 6 weeks/6 months post-intervention
  description: 6 item questionnaire assessing urinary symptoms
  arm group label: Platelet-rich plasma injection
  arm group type: Experimental
  arm group label: 0.9% saline injection
  arm group type: Sham Comparator
  intervention type: Procedure
  intervention name: Injection of platelet-rich plasma
  description: Injection of autologous platelet-rich plasma into anterior vaginal wall
  arm group label: Platelet-rich plasma injection
  intervention type: Procedure
  intervention name: Injection of saline
  description: Injection of sterile normal saline into anterior vaginal wall
  arm group label: 0.9% saline injection
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Neha G Gaddam, M.D.
  phone: 8328650244
  email: neha.g.gaddam@medstar.net
  last name: Neha G Gaddam, M.D.
  email: gaddam.ng@gmail.com
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No