AtherosclerosisPhase 2APPTNCT04103476
Advancing Postmenopausal Preventive Therapy
A Phase 2 study testing Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg in people with Atherosclerosis and Cognitive Decline, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Cognitive Decline
- What is being tested?
- Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a serum estradiol level <30 pg/ml and cessation of regular menses >6 months who are <6 years postmenopausal and 45-59 years old.
Who cannot join
- Women with a hysterectomy
- Clinical signs, symptoms or personal history of cardiovascular disease
- Diabetes mellitus or fasting serum glucose >126 mg/dL
- Life threatening illness with prognosis <5 years
- Cirrhosis or liver disease
- History of deep vein thrombosis or pulmonary embolism
Show all 11Show fewer
- History of breast cancer
- Current use of postmenopausal hormone replacement therapy (HRT) within 1 month of randomization
- Uncontrolled hypertension (>180/>110 mmHg)*
- Plasma triglyceride levels >500 mg/dL
- Serum creatinine >2.0 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California Atherosclerosis Research Unit
Los Angeles, California, 90033
About this study
Official title: Atherosclerosis Intervention With Novel Tissue Selective Estrogen Complex Therapy
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.
Read the detailed description
To conduct a double-blinded, placebo-controlled trial to determine the effects of TSEC therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women. A total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus will be randomized to Bazedoxifene/Conjugated Equine Estrogen (BZA 20 mg/CE 0.45 mg) or placebo. Recruitment will occur over 3 years and the treatment period will be up to 3 years depending on when an individual is randomized. Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms will be the primary trial endpoint. Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms will be the secondary trial endpoint. Three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.
- Conditions
- Atherosclerosis, Cognitive Decline
- Being tested
- Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg, Placebo
- Medical subject headings
- Atherosclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mgCombination product
Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BZA/CE | Experimental | Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg Receives: Combination Product: Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg |
| Placebo | Placebo comparator | Oral matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid artery intima-media thickness
Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms.
Measured: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Secondary outcomes (1)
CCA stiffness
Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms.
Measured: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start13 Apr 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), double-blinded, placebo-controlled trial of BZA/CE versus placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Howard N. Hodis, M.D., University of Southern California
- Investigators
- Howard N. Hodis, MD, Principal investigator, University of Southern California Atherosclerosis Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103476
- Sponsor's protocol ID
- R01AG058691
- Other IDs
- R01AG058691
- Acronym
- APPT
- Status last verified
- Dec 2024
- First submitted
- 20 Sep 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis Intervention With Novel Tissue Selective Estrogen Complex Therapy
- ClinicalTrials.gov ID
- NCT04103476
- Acronym / sponsor ID
- APPT / R01AG058691
- Conditions
- Atherosclerosis, Cognitive Decline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 385 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To conduct a double-blinded, placebo-controlled trial to determine the effects of TSEC therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women. A total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus will be randomized to Bazedoxifene/Conjugated Equine Estrogen (BZA 20 mg/CE 0.45 mg) or placebo. Recruitment will occur over 3 years and the treatment period will be up to 3 years depending on when an individual is randomized. Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms will be the primary trial endpoint. Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms will be the secondary trial endpoint. Three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1), double-blinded, placebo-controlled trial of BZA/CE versus placebo.
| Arm | Type | Receives |
|---|---|---|
| BZA/CE | Experimental | Combination Product: Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mgOral bazedoxifene 20 mg / conjugated estrogens 0.45 mg |
| Placebo | Placebo comparator | Other: PlaceboOral matching placebo |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with a serum estradiol level <30 pg/ml and cessation of regular menses >6 months who are <6 years postmenopausal and 45-59 years old.
Key exclusion criteria (11 listed)
- Women with a hysterectomy
- Clinical signs, symptoms or personal history of cardiovascular disease
- Diabetes mellitus or fasting serum glucose >126 mg/dL
- Life threatening illness with prognosis <5 years
- Cirrhosis or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mgOral bazedoxifene 20 mg / conjugated estrogens 0.45 mg | Combination product | BZA/CE |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Carotid artery intima-media thickness
Time frame: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms.
1 secondary outcome
CCA stiffness
Time frame: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard N. Hodis, MD principal investigator
University of Southern California Atherosclerosis Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg in people with Atherosclerosis and Cognitive Decline, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid artery intima-media thickness (time frame: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.