EndometriosisPhase 4NCT05962034
Thromboxane Function in Women With Endometriosis
A Phase 4 study testing Aspirin in people with Endometriosis, run by Penn State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 23 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Born with a uterus
- 18-45 years old
- With and without endometriosis
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Noll Laboratory
University Park, Pennsylvania, 16802
About this study
Official title: The Role of Thomboxane A2 and it's Receptor in Vascular Regulation in Women With Endometriosis
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Aspirin, Placebo
- Keywords
- Endometriosis, Aspirin
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
650 mg aspirin (Acetylsalicylic acid)
PlaceboOther
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | one dose of aspirin Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Placebo pill Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
change in blood pressure from baseline to maximum
Measured: 1 day
heart rate
change in heart rate from baseline to maximum
Measured: 1 day
pain scale
pain scale rating in response to testing
Measured: 1 day
skin blood flow
change in skin blood flow from baseline to maximum
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jan 2024
- Primary completion1 Jul 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lacy Alexander, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962034
- Sponsor's protocol ID
- 21851
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Thomboxane A2 and it's Receptor in Vascular Regulation in Women With Endometriosis
- ClinicalTrials.gov ID
- NCT05962034
- Acronym / sponsor ID
- 21851
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirinone dose of aspirin |
| Placebo | Placebo comparator | Other: PlaceboPlacebo pill |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Born with a uterus
- 18-45 years old
- With and without endometriosis
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin650 mg aspirin (Acetylsalicylic acid) | Drug | Aspirin |
| Placeboplacebo capsule | Other | Placebo |
Primary outcome
blood pressure
Time frame: 1 day
change in blood pressure from baseline to maximum
heart rate
Time frame: 1 day
change in heart rate from baseline to maximum
pain scale
Time frame: 1 day
pain scale rating in response to testing
skin blood flow
Time frame: 1 day
change in skin blood flow from baseline to maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Endometriosis, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.