Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee (NCT05059626) | Clinical Trial Compass
By InvitationPhase 4
Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
United States28 participantsStarted 2023-12-01
Plain-language summary
Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis.
Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<10 years prior, and reported by the subject to the researchers)
* Tylenol if the subject has acute pain is allowed
* IUD contraceptive use (copper or levonogestrel) 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in skin blood flow
Timeframe: before intervention and 30 days post-intervention
2
Change in peripheral blood flow
Timeframe: before intervention and 30 days post-intervention