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Hormone Therapy

Hormone Therapy for Prediabetes in Postmenopausal Women (CE/BZA Trial)

Phase 2
Waitlist Available
Led By Dragana Lovre, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50-60 years
GFR >60mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in liver fat between baseline and 16 weeks
Awards & highlights

CE/BZA Trial Summary

This trial will look at the effect of a new hormone therapy on blood sugar, fats in the blood and liver, in obese women who are Veterans.

Who is the study for?
This trial is for postmenopausal women veterans aged 50-60, within 5 years of menopause, who are overweight or have low-risk obesity. They should have prediabetes with specific blood sugar levels and no history of severe diseases like cancer or clotting disorders. Participants must not be on certain medications that affect weight, glucose, or lipids recently.Check my eligibility
What is being tested?
The study tests a hormone therapy called CE/BZA against a placebo to see its effects on blood sugar and fats in obese menopausal women with prediabetes. It aims to understand if this treatment can help manage glucose and lipid levels better than no treatment.See study design
What are the potential side effects?
While the side effects aren't specified here, typical risks from estrogen therapies may include nausea, headaches, increased risk of blood clots and stroke especially in predisposed individuals. Placebo generally has no side effects but can cause injection site reactions.

CE/BZA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 60 years old.
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My kidney function is normal or only mildly reduced.
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I experience moderate to severe hot flashes or sweating.

CE/BZA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in liver fat between baseline and 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in liver fat between baseline and 16 weeks 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 beta cell function
Secondary outcome measures
change in liver fat
change in serum lipidomics

CE/BZA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: conjugated estrogens/bazedoxifene (CE/BZA)Experimental Treatment1 Intervention
Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg. Recommended and only FDA approved dosage is one CE/BZA tablet daily, taken without regard to meals. Tablets should be swallowed whole. If a dose of BZA/CE is missed, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications.
Group II: PlaceboPlacebo Group1 Intervention
Participants assigned to placebo will receive a daily tablet. To assure the blind is maintain, participants in the placebo group will be given the same instructions for taking the study medication. Tablets should be swallowed whole. If a dose, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about CE/BZA and its potential side effects and contraindications, again to maintain the blind.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,563 Total Patients Enrolled
Dragana Lovre, MDPrincipal InvestigatorSoutheast Louisiana Veterans Health Care System, New Orleans, LA
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Conjugated Estrogens/Bazedoxifene (CE/BZA) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05073237 — Phase 2
Prediabetes Research Study Groups: Placebo, conjugated estrogens/bazedoxifene (CE/BZA)
Prediabetes Clinical Trial 2023: Conjugated Estrogens/Bazedoxifene (CE/BZA) Highlights & Side Effects. Trial Name: NCT05073237 — Phase 2
Conjugated Estrogens/Bazedoxifene (CE/BZA) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073237 — Phase 2

Frequently Asked Questions

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

Are there any documented precedents of research utilizing conjugated estrogens/bazedoxifene (CE/BZA)?

"Currently, 15 clinical trials involving conjugated estrogens/bazedoxifene (CE/BZA) are being conducted worldwide. One of these is currently at Phase 3 and 31 sites in League City, Texas alone are running studies on this medication."

Answered by AI

Does this research program restrict participation to those over a certain age?

"This clinical trial is only open to individuals aged 50-60. There are 214 medical experiments that offer inclusion criteria for persons under 18 years old, and 760 trials available to those over 65."

Answered by AI

Are enrollment slots available to participate in this research?

"Based on the information posted to clinicaltrials.gov, this trial is not presently accepting patients. It was initially listed on September 1st 2023 and most recently updated on July 19th 2022; yet there are 1177 other medical studies currently seeking participants at present."

Answered by AI

Is participation in this clinical trial available to me?

"This trial seeks 40 postmenopausal women aged 50-60, with a BMI between 27-34.9kg/m2 and moderate to severe vasomotor symptoms related to obesity. Participants must also have had their last menstrual period within the past 5 years but >1 year ago."

Answered by AI

How many participants are necessary to complete this scientific experiment?

"Unfortunately, recruitment for this trial has concluded. This program was initially posted on September 1st 2023 and the most recent edit occurred on July 19th 2022. For those seeking to participate in similar trials, 1162 obesity studies are currently open as well as 15 clinical trials involving conjugated estrogens/bazedoxifene (CE/BZA)."

Answered by AI

What medical indications has conjugated estrogens/bazedoxifene (CE/BZA) been proven to assuage?

"Conjugated estrogens/bazedoxifene (CE/BZA) is a medication typically prescribed to treat premature menopause. In addition, this pharmaceutical can be employed therapeutically for female castration, hot flashes associated with the vasomotor system and traditional menopausal signs."

Answered by AI

Has the Food and Drug Administration (FDA) sanctioned conjugated estrogens/bazedoxifene (CE/BZA)?

"Our assessment at Power of the safety profile for conjugated estrogens/bazedoxifene (CE/BZA) is 2. This comes as a result of this being an experimental Phase 2 trial, without efficacy data but with some preliminary safety information available."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans
2024. "Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05073237.
All > Prediabetes > Menopause
~27 spots leftby Sep 2025
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