MenopausePhase 2CE/BZANCT05073237
Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans
A Phase 2 study testing conjugated estrogens/bazedoxifene (CE/BZA) in people with Menopause and Prediabetes, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of a novel menopause hormone therapy on blood sugar (glucose) and blood and liver fats (lipids) in obese menopausal women Veterans. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Menopause, Prediabetes, Obesity
- What is being tested?
- conjugated estrogens/bazedoxifene (CE/BZA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 8 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postmenopausal women veterans within 5 years of menopause.
- Menopause is defined as:
- women with intact uterus and last menstrual period >1 year ago but <5 years ago
- Age 50-60 years
- BMI 27-34.9kg/m2 (Overweight and low risk Class 1 Obesity)
- Symptomatic (moderate to severe vasomotor symptoms)
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- Fasting glucose 100-150mg/dl or/or HbA1c >5.7%- and <7% (two abnormal test can be fasting glucose or HbA1c or combination of the two in the past 6 months).
- Triglycerides < 200 mg/dl
- GFR >60mL/min
- Normal mammogram within the past 12 months
Who cannot join
- Amenorrhea from other causes (Hyperandrogenemia and anovulation)
- Recent weight change (>10 lbs in the last 3 months), intended or unintended
- Vulnerable populations (employees, students, individuals with impaired decision making capacity, pregnant women, prisoners, terminally ill, and children)
- Change in lipid lowering agent in the last 3 months
- Use of glucose lowering agents in the last 3 months
- Concurrent conditions including HIV, uncontrolled hyperthyroidism, uncontrolled hypothyroidism or less than 3 months since addition or change in thyroid hormone modulating medications, current use of drugs known to promote significant weight changes, menopause hormone therapy use within 3 months
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- Contraindications to estrogens (history of thromboembolic disorder, coronary artery or cerebrovascular disease, clotting disorders (Antiphospholipid antibody syndrome, protein C deficiency, protein S deficiency, AT III deficiency, factor V leiden), severe liver disease, history of breast or uterine cancer or unexplained vaginal bleeding)
- Plan for major surgery or prolonged immobilization within 6 month period
- MRI Absolute contraindications
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70119
About this study
The purpose of this study is to determine the effect of a novel menopause hormone therapy on blood sugar (glucose) and blood and liver fats (lipids) in obese menopausal women Veterans.
Read the detailed description
Menopause is a natural process characterized by estrogen deficiency that results in several undesirable metabolic changes, including increase in body fat, decrease in lipid oxidation, impairment in glucose tolerance, and hyperinsulinemia. One in four women dies of cardiovascular disease (CVD), and with the increase in life expectancy, many women will spend almost half of their lives in a postmenopausal state of estrogen deficiency that predisposes them to metabolic syndrome, hyperlipidemia (HLD) and type 2 diabetes (T2D) resulting in overall increased risk for CVD. Menopausal hormone therapy (MHT) is beneficial if administered in early menopausal women, age 50-60 years . The most promising and novel MHT involves the combination of conjugated estrogens (CE) with the selective estrogen receptor modulator bazedoxifene (BZA) in a single tablet. The major innovation of CE/BZA is that it provides all the advantages of CE treatment without the use and side effects of a progestin. Moreover, an important beneficial effect of estrogen is also to prevent postmenopausal metabolic disorders . One of the most comprehensive research initiatives undertaken on the postmenopausal health of women, The Women's Health Initiative (WHI), involved nearly 4,000 women Veterans. The studies from WHI show how military service affects women's longevity and overall health as compared to non-Veterans. The data from WHI shows that women Veterans have higher all-cause mortality rates than non-Veterans and higher hip fracture rates despite similar risk factors. Also, women Veterans <65 years at WHI enrollment were more likely to have experienced prior hysterectomy and early hysterectomy before age 40 compared with non-Veterans.
Additionally, information about the effectiveness of CE/BZA as MHT in women with abnormal glucose is lacking. In that regard, there is a critical need to determine the effects of CE/BZA on beta cell function in obese menopausal women with early glucose abnormalities, primarily in the pre-diabetes and early diabetes stages, and prevent evolution toward full-blown diabetes as these women are at higher risk for CVD.
In the current study, 40 women Veterans with obesity, prediabetes and menopause who are experiencing bothersome menopause symptoms will be enrolled and randomized to receive either 16 weeks of CE/BZA or 16 weeks of placebo to find the effect of the drug on glucose and lipids metabolism.
- Conditions
- Menopause, Prediabetes, Obesity
- Being tested
- Placebo, conjugated estrogens/bazedoxifene (CE/BZA)
- Keywords
- Menopause, prediabetes, diabetes, obesity, hot flushes, hormones, estrogen, bazedoxifene
- Medical subject headings
- Prediabetic State, Obesity, Diabetes Mellitus, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Daily placebo tablet
conjugated estrogens/bazedoxifene (CE/BZA)Drug
Also called DUAVEE
Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20mg.
| Study group | Role | What they receive |
|---|---|---|
| conjugated estrogens/bazedoxifene (CE/BZA) | Experimental | 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. Receives: Drug: conjugated estrogens/bazedoxifene (CE/BZA) |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in beta cell function
beta cell function will be evaluated via oral glucose tolerance test at baseline and after 16 weeks of treatment.
Measured: Change in beta cell function between baseline and 16 weeks
Secondary outcomes (2)
change in liver fat
Change in liver fat will be evaluated via MRI-PDFF between baseline and after 16 weeks of treatment.
Measured: Change in Liver fat between baseline and 16 weeks
change in serum lipidomics
Change in serum lipidomics will be evaluated via UPLC-MS/MS at baseline and after 16 weeks of treatment.
Measured: Change in serum lipidomics between baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start8 Apr 2024
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Why it stopped: withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- In the current study, 40 women veterans with obesity, prediabetes and menopause who are experiencing bothersome menopause symptoms will be enrolled and randomized to receive either 16 weeks of CE/BZA or 16 weeks of placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dragana Lovre, MD, Principal investigator, Southeast Louisiana Veterans Health Care System, New Orleans, LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073237
- Sponsor's protocol ID
- ENDA-009-20F
- Other IDs
- 1IK2CX002225-01A1
- Acronym
- CE/BZA
- Status last verified
- May 2024
- First submitted
- 28 Sep 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans
- ClinicalTrials.gov ID
- NCT05073237
- Acronym / sponsor ID
- CE/BZA / ENDA-009-20F
- Conditions
- Menopause, Prediabetes, Obesity
- Keywords
- Menopause, prediabetes, diabetes, obesity, hot flushes, hormones, estrogen, bazedoxifene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 11 Oct 2021 (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.
The purpose of this study is to determine the effect of a novel menopause hormone therapy on blood sugar (glucose) and blood and liver fats (lipids) in obese menopausal women Veterans.
Detailed description
Menopause is a natural process characterized by estrogen deficiency that results in several undesirable metabolic changes, including increase in body fat, decrease in lipid oxidation, impairment in glucose tolerance, and hyperinsulinemia. One in four women dies of cardiovascular disease (CVD), and with the increase in life expectancy, many women will spend almost half of their lives in a postmenopausal state of estrogen deficiency that predisposes them to metabolic syndrome, hyperlipidemia (HLD) and type 2 diabetes (T2D) resulting in overall increased risk for CVD. Menopausal hormone therapy (MHT) is beneficial if administered in early menopausal women, age 50-60 years . The most promising and novel MHT involves the combination of conjugated estrogens (CE) with the selective estrogen receptor modulator bazedoxifene (BZA) in a single tablet. The major innovation of CE/BZA is that it provides all the advantages of CE treatment without the use and side effects of a progestin. Moreover, an important beneficial effect of estrogen is also to prevent postmenopausal metabolic disorders . One of the most comprehensive research initiatives undertaken on the postmenopausal health of women, The Women's Health Initiative (WHI), involved nearly 4,000 women Veterans. The studies from WHI show how military service affects women's longevity and overall health as compared to non-Veterans. The data from WHI shows that women Veterans have higher all-cause mortality rates than non-Veterans and higher hip fracture rates despite similar risk factors. Also, women Veterans <65 years at WHI enrollment were more likely to have experienced prior hysterectomy and early hysterectomy before age 40 compared with non-Veterans.
Additionally, information about the effectiveness of CE/BZA as MHT in women with abnormal glucose is lacking. In that regard, there is a critical need to determine the effects of CE/BZA on beta cell function in obese menopausal women with early glucose abnormalities, primarily in the pre-diabetes and early diabetes stages, and prevent evolution toward full-blown diabetes as these women are at higher risk for CVD.
In the current study, 40 women Veterans with obesity, prediabetes and menopause who are experiencing bothersome menopause symptoms will be enrolled and randomized to receive either 16 weeks of CE/BZA or 16 weeks of placebo to find the effect of the drug on glucose and lipids metabolism.
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
- In the current study, 40 women veterans with obesity, prediabetes and menopause who are experiencing bothersome menopause symptoms will be enrolled and randomized to receive either 16 weeks of CE/BZA or 16 weeks of placebo.
| Arm | Type | Receives |
|---|---|---|
| conjugated estrogens/bazedoxifene (CE/BZA) | Experimental | Drug: conjugated estrogens/bazedoxifene (CE/BZA)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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Postmenopausal women veterans within 5 years of menopause.
- women with intact uterus and last menstrual period >1 year ago but <5 years ago
- Age 50-60 years
- BMI 27-34.9kg/m2 (Overweight and low risk Class 1 Obesity)
- Symptomatic (moderate to severe vasomotor symptoms)
Key exclusion criteria (9 listed)
- Amenorrhea from other causes (Hyperandrogenemia and anovulation)
- Recent weight change (>10 lbs in the last 3 months), intended or unintended
- Vulnerable populations (employees, students, individuals with impaired decision making capacity, pregnant women, prisoners, terminally ill, and children)
- Change in lipid lowering agent in the last 3 months
- Use of glucose lowering agents in the last 3 months
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 |
|---|---|---|
| PlaceboDaily placebo tablet | Other | Placebo |
| conjugated estrogens/bazedoxifene (CE/BZA)Also: DUAVEEParticipants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20mg. | Drug | conjugated estrogens/bazedoxifene (CE/BZA) |
Primary outcome
change in beta cell function
Time frame: Change in beta cell function between baseline and 16 weeks
beta cell function will be evaluated via oral glucose tolerance test at baseline and after 16 weeks of treatment.
2 secondary outcomes
change in liver fat
Time frame: Change in Liver fat between baseline and 16 weeks
change in serum lipidomics
Time frame: Change in serum lipidomics between baseline and 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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.
Dragana Lovre, MD principal investigator
Southeast Louisiana Veterans Health Care System, New Orleans, LA
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 conjugated estrogens/bazedoxifene (CE/BZA) in people with Menopause and Prediabetes, run by VA Office of Research and Development 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 10 inclusion and 9 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: withdrawn, as of the sponsor's last update on 10 May 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
change in beta cell function (time frame: Change in beta cell function between baseline and 16 weeks). 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 10 May 2024.