Tissue Selective Estrogen Complex to Prevent Metabolic Dysfunction in Women
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Effect of CE/BZA (TSEC) on Fat Cell Ratio (Small/Large)
研究概览
简要总结
The purpose of this study is to find out if a novel drug approved by the Food and Drug Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by decreasing body fat especially in your liver.
DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of postmenopausal women, the use of estrogens alone can increase the risk of developing cancer of the uterus. So estrogens have been traditionally paired with a progestin to decrease the risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place of a progestin to help protect the uterus against thickening of the uterus that may result from estrogens alone.
In this study, you will get either DUAVEE™ or the placebo (a "dummy pill" that may look like medicine but contains no active medication) first and then switch to the other pill.
详细描述
This study involves a screening process to see if you are eligible to participate followed by two 8-week treatment periods separated by an 8-week washout period. The two 8-week treatments will be with:
- 8 weeks of treatment with TSEC (Duavee™, combination of CE and BZA)
- 8 weeks of treatment with a "dummy pill" (Placebo) The order of these 2 8-week treatment periods will be decided by chance (coin flip).
STUDY VISITS (11 VISITS in total) If you participate in this study, after referral from the Baton Rouge General Obstetrics and Gynecology Physicians, you will complete 1 screening visit at Pennington Biomedical Research Center to determine your eligibility. If you are eligible and enrolled in the study, you will complete an additional 10 visits (8 brief visits and 2 overnight inpatient stays).
Please note all times provided for procedures and the total times for each clinic visit are approximations and may vary depending on circumstances.
SCREENING VISIT (1 visit, approximately 1.5 hours, fasting):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal women (<5y post last period)
- •Age between 50-60y
- •Symptomatic (hot flashes, vaginal dryness) or asymptomatic
- •BMI 30-40 kg/m2
- •Normal mammogram past 12 months
- •Physician clearance (Ob/Gyn or PBRC)
排除标准
- •Amenorrhea other causes (excess androgen)
- •Diabetes mellitus
- •Medications: diabetes, antidepressant uncontrolled depression (2 months stability on SSRIs are fine), antipsychotics, oral steroids, weight loss drugs
- •Tricyclic antidepressants (TCAs)
- •≤ 3 month washout of birth control pill, estrogen, and/or progestin
- •Hysterectomy (total or partial)
- •Contraindications to estrogen treatment
- •Unable or unwilling to do an MRS
研究组 & 干预措施
Drug
TSEC (Duavee™, combination of CE and BZA)
干预措施: TSEC (Tissue-selective estrogen complexes) (Drug)
Drug
TSEC (Duavee™, combination of CE and BZA)
干预措施: Placebo (Other)
Placebo
Non active comparator
干预措施: TSEC (Tissue-selective estrogen complexes) (Drug)
Placebo
Non active comparator
干预措施: Placebo (Other)
结局指标
主要结局
Effect of CE/BZA (TSEC) on Fat Cell Ratio (Small/Large)
时间窗: 8 weeks
Effect of CE/BZA (TSEC) on Mean Fat Cell Size
时间窗: 8 weeks
Effect of CE/BZA (TSEC) on Body Composition
时间窗: 8 weeks
Effect of CE/BZA (TSEC) on Ectopic Fat - 1H-MRS, Proton Magnetic Resonance Spectroscopy
时间窗: 8 weeks
Effect of CE/BZA (TSEC) on Abdominal Fat Cell Size (by Biopsy)
时间窗: 8 weeks
Effect of CE/BZA (TSEC) on Body Mass Index
时间窗: 8 weeks
Effect of CE/BZA (TSEC) on Percent Body Fat
时间窗: 8 weeks
次要结局
- Effect of CE/BZA (TSEC) on Fasting Labs(8 weeks)
- Effect of CE/BZA on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp)(8 weeks)
- Effect of CE/BZA (TSEC) on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) on FFA(8 weeks)
- Effect of CE/BZA (TSEC) on Resting Metabolic Rate & Substrate Oxidation (by Indirect Calorimetry)(8 weeks)
- Effect of CE/BZA (TSEC) on Fasting Insulin(8 weeks)
- Effect of CE/BZA (TSEC) on Fasting Free Fatty Acids(8 weeks)
- Effect of CE/BZA on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) on Glucose(8 weeks)
- Effect of CE/BZA (TSEC) on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) on Insulin(8 weeks)
研究者
Eric Ravussin
Principal Investigator
Pennington Biomedical Research Center