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

NCT05073237 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: ENDA-009-20F1IK2CX002225-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Prediabetes; Obesity

Keywords

Menopause; prediabetes; diabetes; obesity; hot flushes; hormones; estrogen; bazedoxifene

Outcome Measures

Primary Outcomes (1)

• change in beta cell function

  beta cell function will be evaluated via oral glucose tolerance test at baseline and after 16 weeks of treatment.

  Change in beta cell function between baseline and 16 weeks

Secondary Outcomes (2)

• change in liver fat

  Change in Liver fat between baseline and 16 weeks

• change in serum lipidomics

  Change in serum lipidomics between baseline and 16 weeks

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Placebo OTHER

Daily placebo tablet

Placebo

conjugated estrogens/bazedoxifene (CE/BZA) DRUG

Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20mg.

Also known as: DUAVEE

conjugated estrogens/bazedoxifene (CE/BZA)

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Diabetes Mellitus; Hot Flashes

Interventions

Estrogens, Conjugated (USP); bazedoxifene

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dragana Lovre, MD

  Southeast Louisiana Veterans Health Care System, New Orleans, LA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomized, double blind, placebo-controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 11, 2021
• Study Start: April 8, 2024
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)