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/NCT05962034</url>
    </required_header>
    <id_info>
      <org_study_id>21851</org_study_id>
      <nct_id>NCT05962034</nct_id>
    </id_info>
    <brief_title>Thromboxane Function in Women With Endometriosis</brief_title>
    <official_title>The Role of Thomboxane A2 and it's Receptor in Vascular Regulation in Women With Endometriosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Penn State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Penn State University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare neurovascular regulation in women with&#xD;
        endometriosis and healthy women. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Do women with endometriosis have greater blood pressure and pain responses to a stimulus&#xD;
             than healthy women?&#xD;
  &#xD;
          -  Do women with endometriosis have greater platelet activity than healthy women?&#xD;
  &#xD;
        Participants will take aspirin and/or placebo and will:&#xD;
  &#xD;
          -  perform hand grip exercise and cold pressor tests&#xD;
  &#xD;
          -  undergo iontophoresis and blood draw&#xD;
  &#xD;
        Researchers will compare women with and without endometriosis to see if there is a difference&#xD;
        in neurovascular regulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular disease (CVD) is the leading cause of death worldwide. Endometriosis is an&#xD;
        independent risk factor for CVD that affects an estimated one in ten women in the world.&#xD;
        Endometriosis is a gynecologic condition characterized by invasive extrauterine endometriotic&#xD;
        lesions, chronic pain, and systemic inflammation. The expression of thromboxane A2 (TxA2), a&#xD;
        product of the inflammatory cyclooxygenase pathway, is upregulated in endometriotic lesions.&#xD;
        In the vasculature, TxA2 blocks vasodilation, and induces vasoconstriction. TxA2 diffuses&#xD;
        across the innermost layer of cells in the blood vessels, the endothelium, to act directly on&#xD;
        its receptors in the vascular smooth muscle. It also inhibits endothelial nitric oxide&#xD;
        synthase, thereby decreasing nitric oxide (NO)-mediated vasodilation --endothelial&#xD;
        dysfunction which is regarded as a critical early event in the development of atherosclerosis&#xD;
        and overt cardiovascular disease. Women with endometriosis demonstrate marked endothelial&#xD;
        dysfunction compared with healthy controls, but the potential role of TxA2 and its receptors&#xD;
        (TP) in this dysfunction have not been investigated. Furthermore, TP play a key role in&#xD;
        sensitizing the sensory afferent nerve fibers in pre-clinical models of cardiovascular&#xD;
        disease, leading to an exaggerated blood pressure responses to sympathoexcitatory maneuvers&#xD;
        including the exercise pressor reflex. The exercise pressor reflex is the reflex increase in&#xD;
        blood pressure in response to the mechanical and metabolic stimuli of exercise. The&#xD;
        exaggeration of this reflex response is a strong predictor of major adverse cardiovascular&#xD;
        events in cardiovascular disease patients. However, the reflex response to sympathoexcitatory&#xD;
        maneuvers has not been characterized in women with endometriosis. Furthermore, TxA2 is a key&#xD;
        component in the clotting cascade. An increased production of TxA2 in the platelet cells of&#xD;
        women with endometriosis indicates altered platelet function. However, platelet activity in&#xD;
        women with endometriosis has not been characterized.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</primary_completion_date>
    <phase>Phase 4</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>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>blood pressure</measure>
      <time_frame>1 day</time_frame>
      <description>change in blood pressure from baseline to maximum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>heart rate</measure>
      <time_frame>1 day</time_frame>
      <description>change in heart rate from baseline to maximum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>pain scale</measure>
      <time_frame>1 day</time_frame>
      <description>pain scale rating in response to testing</description>
    </primary_outcome>
    <primary_outcome>
      <measure>skin blood flow</measure>
      <time_frame>1 day</time_frame>
      <description>change in skin blood flow from baseline to maximum</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Endometriosis</condition>
    <arm_group>
      <arm_group_label>Aspirin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>one dose of aspirin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo pill</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aspirin</intervention_name>
      <description>650 mg aspirin (Acetylsalicylic acid)</description>
      <arm_group_label>Aspirin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>placebo capsule</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Born with a uterus&#xD;
  &#xD;
            -  18-45 years old&#xD;
  &#xD;
            -  With and without endometriosis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently pregnant or breastfeeding&#xD;
  &#xD;
            -  Diagnosed cardiovascular disease&#xD;
  &#xD;
            -  BMI over 35&#xD;
  &#xD;
            -  Nicotine use (e.g., smoking, chewing tobacco, vaping, etc.)&#xD;
  &#xD;
            -  Currently using hormone replacement therapy (or have used within previous 6 months)&#xD;
  &#xD;
            -  Known skin allergies or current rash, skin disease, disorders of pigmentation&#xD;
  &#xD;
            -  Diabetes&#xD;
  &#xD;
            -  Renal disease, renal artery stenosis, renal impairment&#xD;
  &#xD;
            -  Liver disease&#xD;
  &#xD;
            -  Stage II Hypertension (blood pressure &gt;140/&gt;90 mmHg)&#xD;
  &#xD;
            -  Hypotension (blood pressure &lt; 90/60 mmHg)&#xD;
  &#xD;
            -  Raynaud's syndrome&#xD;
  &#xD;
            -  Any current medications which could conceivably alter cardiovascular responses (e.g.&#xD;
               antihypertension medication, diuretic, digoxin)&#xD;
  &#xD;
            -  Allergy or hypersensitivity to investigational agents&#xD;
  &#xD;
            -  Immunosuppressed/immunocompromised&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Penn State University</investigator_affiliation>
      <investigator_full_name>Lacy Alexander</investigator_full_name>
      <investigator_title>Professor of Kinesiology</investigator_title>
    </responsible_party>
    <keyword>Endometriosis</keyword>
    <keyword>Aspirin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometriosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aspirin</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05962034
  org study id: 21851
  nct id: NCT05962034
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare neurovascular regulation in women with
        endometriosis and healthy women. The main questions it aims to answer are:
  
          -  Do women with endometriosis have greater blood pressure and pain responses to a stimulus
             than healthy women?
  
          -  Do women with endometriosis have greater platelet activity than healthy women?
  
        Participants will take aspirin and/or placebo and will:
  
          -  perform hand grip exercise and cold pressor tests
  
          -  undergo iontophoresis and blood draw
  
        Researchers will compare women with and without endometriosis to see if there is a difference
        in neurovascular regulation.
  Cardiovascular disease (CVD) is the leading cause of death worldwide. Endometriosis is an
        independent risk factor for CVD that affects an estimated one in ten women in the world.
        Endometriosis is a gynecologic condition characterized by invasive extrauterine endometriotic
        lesions, chronic pain, and systemic inflammation. The expression of thromboxane A2 (TxA2), a
        product of the inflammatory cyclooxygenase pathway, is upregulated in endometriotic lesions.
        In the vasculature, TxA2 blocks vasodilation, and induces vasoconstriction. TxA2 diffuses
        across the innermost layer of cells in the blood vessels, the endothelium, to act directly on
        its receptors in the vascular smooth muscle. It also inhibits endothelial nitric oxide
        synthase, thereby decreasing nitric oxide (NO)-mediated vasodilation --endothelial
        dysfunction which is regarded as a critical early event in the development of atherosclerosis
        and overt cardiovascular disease. Women with endometriosis demonstrate marked endothelial
        dysfunction compared with healthy controls, but the potential role of TxA2 and its receptors
        (TP) in this dysfunction have not been investigated. Furthermore, TP play a key role in
        sensitizing the sensory afferent nerve fibers in pre-clinical models of cardiovascular
        disease, leading to an exaggerated blood pressure responses to sympathoexcitatory maneuvers
        including the exercise pressor reflex. The exercise pressor reflex is the reflex increase in
        blood pressure in response to the mechanical and metabolic stimuli of exercise. The
        exaggeration of this reflex response is a strong predictor of major adverse cardiovascular
        events in cardiovascular disease patients. However, the reflex response to sympathoexcitatory
        maneuvers has not been characterized in women with endometriosis. Furthermore, TxA2 is a key
        component in the clotting cascade. An increased production of TxA2 in the platelet cells of
        women with endometriosis indicates altered platelet function. However, platelet activity in
        women with endometriosis has not been characterized.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: blood pressure
  time frame: 1 day
  description: change in blood pressure from baseline to maximum
  measure: heart rate
  time frame: 1 day
  description: change in heart rate from baseline to maximum
  measure: pain scale
  time frame: 1 day
  description: pain scale rating in response to testing
  measure: skin blood flow
  time frame: 1 day
  description: change in skin blood flow from baseline to maximum
  arm group label: Aspirin
  arm group type: Experimental
  description: one dose of aspirin
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo pill
  intervention type: Drug
  intervention name: Aspirin
  description: 650 mg aspirin (Acetylsalicylic acid)
  arm group label: Aspirin
  intervention type: Other
  intervention name: Placebo
  description: placebo capsule
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Penn State University
  investigator full name: Lacy Alexander
  investigator title: Professor of Kinesiology
  mesh term: Endometriosis
  mesh term: Aspirin