Thromboxane Function in Women With Endometriosis

Sponsor

Penn State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05962034

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Aspirin Other: Placebo	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

The Role of Thomboxane A2 and it's Receptor in Vascular Regulation in Women With Endometriosis

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aspirin one dose of aspirin	Drug: Aspirin 650 mg aspirin (Acetylsalicylic acid)
Placebo Comparator: Placebo Placebo pill	Other: Placebo placebo capsule

Arm

Intervention/Treatment

Experimental: Aspirin

one dose of aspirin

Drug: Aspirin

650 mg aspirin (Acetylsalicylic acid)

Placebo Comparator: Placebo

Placebo pill

Other: Placebo

placebo capsule

Outcome Measures

Primary Outcome Measures

blood pressure [1 day]
change in blood pressure from baseline to maximum
heart rate [1 day]
change in heart rate from baseline to maximum
pain scale [1 day]
pain scale rating in response to testing
skin blood flow [1 day]
change in skin blood flow from baseline to maximum

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lacy Alexander, Professor of Kinesiology, Penn State University

ClinicalTrials.gov Identifier:

NCT05962034

Other Study ID Numbers:

21851

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lacy Alexander, Professor of Kinesiology, Penn State University

Endometriosis

Aspirin

Additional relevant MeSH terms:

Endometriosis

Aspirin

Study Results

No Results Posted as of Jul 27, 2023