Thromboxane Function in Women With Endometriosis
The Role of Thomboxane A2 and it's Receptor in Vascular Regulation in Women With Endometriosis
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
May 4, 2025
May 1, 2025
2.6 years
June 30, 2023
May 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
blood pressure
change in blood pressure from baseline to maximum
1 day
heart rate
change in heart rate from baseline to maximum
1 day
pain scale
pain scale rating in response to testing
1 day
skin blood flow
change in skin blood flow from baseline to maximum
1 day
Study Arms (2)
Aspirin
EXPERIMENTALone dose of aspirin
Placebo
PLACEBO COMPARATORPlacebo pill
Interventions
Eligibility Criteria
You may qualify if:
- Born with a uterus
- years old
- With and without endometriosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Noll Laboratory
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Kinesiology
Study Record Dates
First Submitted
June 30, 2023
First Posted
July 27, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
May 4, 2025
Record last verified: 2025-05