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

ENDA-009-20F

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.

2024-04-08

2024-04-08

2024-04-08

Withdrawn

Early phase I

Inclusion Criteria: 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'randomized, double blind, placebo-controlled trial', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-05-10