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New treatment option for Endometriosis
Official title Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
ClinicalTrials.gov ID: NCT05059626
What this study is testing
What is simvastatin 10mg?
simvastatin 10mg is an investigational medicine, being studied as a potential treatment for endometriosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<10 years prior, and...
- Tylenol if the subject has acute pain is allowed
- IUD contraceptive use (copper or levonogestrel) is allowed
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.