Bazedoxifene + Estrogens for Atherosclerosis
(APPT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byHoward N. Hodis, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Southern California

Prior Safety Data

Trial Summary

What is the purpose of this trial?Advancing Postmenopausal Preventive Therapy (APPT) is a randomized, double-blinded, placebo-controlled trial designed to determine the effects of tissue selective estrogen complex (TSEC) therapy on the progression of subclinical atherosclerosis and cognitive decline in 360 healthy postmenopausal women.

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 45-59, less than 6 years postmenopausal, with low estrogen levels.

Exclusion Criteria

I have a history of heart problems.

Your blood test shows that you have high levels of creatinine, which is a waste product in the blood.

I have been using hormone replacement therapy for the past month.

+8 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BZA/CEExperimental Treatment1 Intervention

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Group II: PlaceboPlacebo Group1 Intervention

Oral matching placebo