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Selective Estrogen Receptor Modulator

Simvastatin + Duavee for Endometriosis(Endo2/SA3 Trial)

Phase 4

Recruiting

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tylenol if the subject has acute pain is allowed

Be between 18 and 65 years old

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbefore intervention and 30 days post-intervention

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal 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 Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You can take Tylenol if you have temporary pain.

Endo2/SA3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before intervention and 30 days post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before intervention and 30 days post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and before intervention and 30 days post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in peripheral blood flow

Change in skin blood flow

Secondary outcome measures

Change in LOX-1 activity

Change in inflammation

Body Weight Changes

+1 more

Awards & Highlights

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.

Endo2/SA3 Trial Design

2Treatment groups

Experimental Treatment

Group I: bazedoxifene + conjugated estrogenExperimental Treatment1 Intervention

30 days of bazedoxifene + conjugated estrogen (0.45mg/20mg/day)

Group II: SimvastatinExperimental Treatment1 Intervention

30 days of Simvastatin (10mg/day)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor

348 Previous Clinical Trials

125,130 Total Patients Enrolled

4 Trials studying Endometriosis

244 Patients Enrolled for Endometriosis

The John B. Pierce LaboratoryOTHER

2 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Bazedoxifene/Estrogens,Conjugated (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05059626 — Phase 4

Endometriosis Research Study Groups: bazedoxifene + conjugated estrogen, Simvastatin

Endometriosis Clinical Trial 2023: Bazedoxifene/Estrogens,Conjugated Highlights & Side Effects. Trial Name: NCT05059626 — Phase 4

Bazedoxifene/Estrogens,Conjugated (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05059626 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Lacy Alexander 2023. "Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05059626.

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