Bazedoxifene + Estrogens for Atherosclerosis (APPT Trial)

Phase 2

Recruiting

Led By Howard N. Hodis, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

Clinical signs, symptoms or personal history of cardiovascular disease

Life threatening illness with prognosis <5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization

Summary

This trial is designed to test the effects of a tissue selective estrogen complex on the progression of subclinical atherosclerosis and cognitive decline in 360 postmenopausal women.

Who is the study for?

This trial is for healthy postmenopausal women aged 45-59, within six years of menopause and with low estrogen levels. It's not for those who've had a hysterectomy, cardiovascular disease, diabetes, severe illness with short prognosis, liver disease, blood clots in veins or lungs, breast cancer history or recent hormone therapy.

What is being tested?

The APPT study tests if a combo pill (bazedoxifene and conjugated estrogens) can slow down heart artery hardening and mental decline compared to a placebo. The trial randomly assigns participants to either the treatment or placebo group in secret.

What are the potential side effects?

Possible side effects include typical symptoms associated with estrogen therapy such as nausea, headaches, swelling due to fluid retention and potential increased risk of blood clots.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of heart problems.

Select...

My doctor expects I have less than 5 years to live due to my illness.

Select...

I have had breast cancer in the past.

Select...

My blood pressure is not higher than 180/110 mmHg.

Select...

I have had a deep vein thrombosis or pulmonary embolism.

Select...

I have cirrhosis or another liver disease.

Select...

I have diabetes or my blood sugar level is high.

Select...

I have had a hysterectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization for reporting.