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Thromboxane Function in Women With Endometriosis

Primary Purpose

Endometriosis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aspirin
Placebo
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometriosis focused on measuring Endometriosis, Aspirin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Born with a uterus 18-45 years old With and without endometriosis Exclusion Criteria: Currently pregnant or breastfeeding Diagnosed cardiovascular disease BMI over 35 Nicotine use (e.g., smoking, chewing tobacco, vaping, etc.) Currently using hormone replacement therapy (or have used within previous 6 months) Known skin allergies or current rash, skin disease, disorders of pigmentation Diabetes Renal disease, renal artery stenosis, renal impairment Liver disease Stage II Hypertension (blood pressure >140/>90 mmHg) Hypotension (blood pressure < 90/60 mmHg) Raynaud's syndrome Any current medications which could conceivably alter cardiovascular responses (e.g. antihypertension medication, diuretic, digoxin) Allergy or hypersensitivity to investigational agents Immunosuppressed/immunocompromised

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Aspirin

    Placebo

    Arm Description

    one dose of aspirin

    Placebo pill

    Outcomes

    Primary Outcome Measures

    blood pressure
    change in blood pressure from baseline to maximum
    heart rate
    change in heart rate from baseline to maximum
    pain scale
    pain scale rating in response to testing
    skin blood flow
    change in skin blood flow from baseline to maximum

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2023
    Last Updated
    July 18, 2023
    Sponsor
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05962034
    Brief Title
    Thromboxane Function in Women With Endometriosis
    Official Title
    The Role of Thomboxane A2 and it's Receptor in Vascular Regulation in Women With Endometriosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2026 (Anticipated)
    Study Completion Date
    August 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Penn State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometriosis
    Keywords
    Endometriosis, Aspirin

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aspirin
    Arm Type
    Experimental
    Arm Description
    one dose of aspirin
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo pill
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Intervention Description
    650 mg aspirin (Acetylsalicylic acid)
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo capsule
    Primary Outcome Measure Information:
    Title
    blood pressure
    Description
    change in blood pressure from baseline to maximum
    Time Frame
    1 day
    Title
    heart rate
    Description
    change in heart rate from baseline to maximum
    Time Frame
    1 day
    Title
    pain scale
    Description
    pain scale rating in response to testing
    Time Frame
    1 day
    Title
    skin blood flow
    Description
    change in skin blood flow from baseline to maximum
    Time Frame
    1 day

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Born with a uterus 18-45 years old With and without endometriosis Exclusion Criteria: Currently pregnant or breastfeeding Diagnosed cardiovascular disease BMI over 35 Nicotine use (e.g., smoking, chewing tobacco, vaping, etc.) Currently using hormone replacement therapy (or have used within previous 6 months) Known skin allergies or current rash, skin disease, disorders of pigmentation Diabetes Renal disease, renal artery stenosis, renal impairment Liver disease Stage II Hypertension (blood pressure >140/>90 mmHg) Hypotension (blood pressure < 90/60 mmHg) Raynaud's syndrome Any current medications which could conceivably alter cardiovascular responses (e.g. antihypertension medication, diuretic, digoxin) Allergy or hypersensitivity to investigational agents Immunosuppressed/immunocompromised

    12. IPD Sharing Statement

    Learn more about this trial

    Thromboxane Function in Women With Endometriosis

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