NCT05069740 Endometriosis and Microvascular Dysfunction: Role of Inflammation
| NCT ID | NCT05069740 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Penn State University |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2022-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.
Eligibility Criteria
Inclusion Criteria: * Healthy women between the ages of 18 and 45 years (Controls), taking oral contraceptive or with regular menses every 26-34 days * Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<5 years prior, and reported by the subject to the researchers) * Tylenol if the subject has acute pain is allowed * Contraceptive use is allowed Exclusion Criteria: * Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.) * Diabetes (HbA1C 6.5%) * BP\>140/90 * Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications) * Pregnancy * Breastfeeding * Taking illicit and/or recreational drugs * Abnormal liver function * Rash, skin disease, disorders of pigmentation, known skin allergies * Diagnosed or suspected metabolic or cardiovascular disease * Persistent unexplained elevations of serum transaminases * Known allergy to latex or investigative substances (including salsalate or simvastatin) * History of gastrointestinal bleeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05069740 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05069740 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05069740 currently recruiting?
Yes, NCT05069740 is actively recruiting participants. Contact the research team at lma191@psu.edu for enrollment information.
Where is the NCT05069740 trial being conducted?
This trial is being conducted at University Park, United States.
Who is sponsoring the NCT05069740 clinical trial?
NCT05069740 is sponsored by Penn State University. The trial plans to enroll 24 participants.