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Tissue Selective Estrogen Complex

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
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
Awards & highlights

APPT Trial 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.Check my eligibility
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.See study design
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.

APPT Trial 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
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Carotid Arteries
Secondary outcome measures
CCA stiffness
Other outcome measures
Cognitive decline

APPT Trial Design

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

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,485 Total Patients Enrolled
16 Trials studying Atherosclerosis
30,896 Patients Enrolled for Atherosclerosis
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,595,888 Total Patients Enrolled
8 Trials studying Atherosclerosis
1,543 Patients Enrolled for Atherosclerosis
Howard N. Hodis, MDPrincipal Investigator - University of Southern California Atherosclerosis Research Unit
University of Southern California
8 Previous Clinical Trials
2,764 Total Patients Enrolled
8 Trials studying Atherosclerosis
2,764 Patients Enrolled for Atherosclerosis

Media Library

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg (Tissue Selective Estrogen Complex) Clinical Trial Eligibility Overview. Trial Name: NCT04103476 — Phase 2
Atherosclerosis Research Study Groups: Placebo, BZA/CE
Atherosclerosis Clinical Trial 2023: Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg Highlights & Side Effects. Trial Name: NCT04103476 — Phase 2
Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg (Tissue Selective Estrogen Complex) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04103476 — Phase 2

Frequently Asked Questions

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

Are recruitment efforts still underway for this experiment?

"According to the official clinicaltrials.gov page, applications for this trial are still being accepted. This study was initially announced on April 13th 2021 and has since been updated as of June 30th 2022."

Answered by AI

What criteria are necessary for enrolment in this clinical experiment?

"This investigation is recruiting up to 400 individuals with atherogenesis who are between 45 and 59 years old."

Answered by AI

What adverse effects have been observed when taking Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg?

"With Phase 2 clinical data confirming its safety, our team at Power assigned Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg a score of 2 on the 1-3 scale. No efficacy studies have been conducted yet."

Answered by AI

Could you please elucidate the past experiments involving Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg?

"Currently, Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg is being investigated in 15 clinical trials with one of them in the final stage of evaluation. Most studies are found in League City, Texas while 31 sites across the country have opened up recruitment for this medication."

Answered by AI

Is eligibility for this experiment limited to individuals aged 25 or above?

"To be considered for this clinical trial, prospective participants must fall within the age range of 45-59. There are 26 studies recruiting patients under 18 years old and 662 aiming to enroll persons that have exceeded 65 years of life."

Answered by AI

What medical conditions have been effectively managed with Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg?

"Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg is a viable treatment for premature menopause, female castration, and vasomotor system issues."

Answered by AI

What is the aggregate size of participants in this clinical research?

"Affirmative. According to the clinicaltrials.gov website, recruitment is still open for this trial which was first posted on April 13th 2021 and updated most recently on June 30th 2022. The researchers are looking to sign up 400 individuals at a single site."

Answered by AI
~182 spots leftby Oct 2026