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Simvastatin + Duavee for Endometriosis(Endo2/SA3 Trial)
Endo2/SA3 Trial Summary
This trial is testing whether two different treatments can improve heart function in women with endometriosis by reducing inflammation.
Endo2/SA3 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Endo2/SA3 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
Endo2/SA3 Trial Design
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Who is running the clinical trial?
- If you are currently breastfeeding, you cannot participate in the study.You are not allowed to use illegal drugs or substances for fun.You have a skin condition such as a rash, skin disease, or known skin allergies.You are allergic to latex or any of the substances being used in the study.You are currently taking medications that can affect how your blood vessels work, like medications for diabetes or heart problems.You can take Tylenol if you have temporary pain.
- Group 1: bazedoxifene + conjugated estrogen
- Group 2: Simvastatin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the potential risks associated with 10mg daily doses of simvastatin?
"Based on its Phase 4 trial status, simvastatin 10mg is deemed to have a safety rating of 3."
Who are the eligible participants for this clinical trial?
"This research trial is open to 28 individuals aged 18-45 years old suffering from endometrioma. To be considered, applicants must adhere to the following conditions: taking Tylenol for acute pain is acceptable."
How many participants are currently involved in this research?
"Affirmative. According to the clinicaltrials.gov database, this medical experiment is actively recruiting patients; it was first posted on January 1st 2022 and has since been revised November 8th of the same year. 28 participants are required from a single site for successful completion of the study."
Is the eligibility criteria for this research study limited to individuals under 35 years of age?
"The requirements to qualify for this clinical trial are that applicants lie between the ages of eighteen and forty-five. For those under 18, there are nine trials available while seventy exist for individuals over 65 years old."
What is the purpose of this experiment?
"This trial, to be evaluated in a before-and-after timeframe of 30 days, aims at assessing alterations in peripheral blood flow. Additionally, secondary goals include measuring changes in reproductive hormones concentrations, inflammation cytokine concentration and LOX-1 receptor expression."
Is there currently an opportunity for patients to participate in this experiment?
"This clinical trial, which first went live on the 1st of January 2022, is currently enrolling patients. According to its latest update from 8th November 2022 it can be found on clinicaltrials.gov."
What is typically the purpose of dosing with simvastatin 10mg?
"Simvastatin 10mg is often recommended for treating hypercholesterolemia. It has been proven to be effective in managing advanced androgen dependent prostate cancer, amenorrhea, and hypoestrogenism as well."
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