NCT05073237

Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: Female
• Age: 50 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Placebo	Daily placebo tablet
DRUG	conjugated estrogens/bazedoxifene (CE/BZA)	Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20mg.

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-04-08
• Completion: 2024-04-08
• First posted: 2021-10-11
• Last updated: 2024-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study