A Phase 2 interventional study of Placebo and conjugated estrogens/bazedoxifene (CE/BZA) in Menopause, Prediabetes and Obesity, sponsored by VA Office of Research and Development. Withdrawn at 1 site in United States. Open to female participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
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.
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.
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Postmenopausal women veterans within 5 years of menopause.
Menopause is defined as:
Exclusion Criteria:
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.
Drug: conjugated estrogens/bazedoxifene (CE/BZA)
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.
Other: Placebo
Daily placebo tablet
Drug page: Conjugated Estrogens/Bazedoxifene
Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20mg.
Also known as: DUAVEE
change in beta cell function
beta cell function will be evaluated via oral glucose tolerance test at baseline and after 16 weeks of treatment.
Time frame: Change in beta cell function between baseline and 16 weeks
change in liver fat
Change in liver fat will be evaluated via MRI-PDFF between baseline and after 16 weeks of treatment.
Time frame: 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.
Time frame: Change in serum lipidomics between baseline and 16 weeks
Plan to share: No
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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Conjugated Estrogens/Bazedoxifene
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