Thromboxane Function in Women With Endometriosis

NCT ID: NCT05962034

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-08-01

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Aspirin

one dose of aspirin

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

650 mg aspirin (Acetylsalicylic acid)

Placebo

Placebo pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo capsule

Interventions

Aspirin

650 mg aspirin (Acetylsalicylic acid)

Intervention Type: DRUG

Placebo

placebo capsule

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Lacy Alexander

Professor of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Noll Laboratory

University Park, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lacy Alexander, Ph.D.

Role: CONTACT

lma191@psu.edu

8148671781

Sue Slimak, RN

Role: CONTACT

sks31@psu.edu

8148638556

Facility Contacts

Lacy Alexander, Ph.D.

Role: primary

lma191@psu.edu

814-867-1781

Other Identifiers

21851

Identifier Type: -

Identifier Source: org_study_id