Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM) (BIM)
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ClinicalTrials.gov Identifier: NCT02237079 |
Recruitment Status :
Completed
First Posted : September 11, 2014
Last Update Posted : July 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Obesity Glucose Homeostasis Postmenopausal Symptoms | Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE) Drug: Placebo Oral Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM) |
Actual Study Start Date : | December 2014 |
Actual Primary Completion Date : | April 2018 |
Actual Study Completion Date : | April 2018 |

Arm | Intervention/treatment |
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Experimental: Bazedoxifene/Conjugated Estrogens (BZA/CE)
Participants assigned to BZA/CE will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg. BZA/CE (bazedoxifene/conjugated estrogens) tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. The recommended and only FDA approved dosage is one BZA/CE 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.
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Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)
Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
Other Name: DUAVEE |
Placebo Comparator: Placebo
Participants assigned to placebo will receive a daily tablet that matches the BZA/CE to maintain the blind. Placebo tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. Also 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 BZA/CE and its potential side effects and contraindications, again to maintain the blind.
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Drug: Placebo Oral Tablet
Daily placebo tablet |
- Body composition [ Time Frame: Change at 3 months from baseline ]Body composition will be assessed through change in body mass index (BMI), waist to hip circumference (WHR), and body composition DEXA scans conducted at baseline and at 3 months post-treatment. The change in 3 months will show if BZA/CE has any effect on decreasing abdominal fat.
- Glucose Homeostasis [ Time Frame: Change at 3 months from baseline ]This will be assessed through a 2-hour IV Glucose Tolerance Tests conducted at baseline and 3 months. The changes in glucose and insulin levels throughout the test will determine if the body is able to process glucose normally.
- Systematic Inflammation [ Time Frame: Change at 3 months from baseline ]Systematic inflammation will be measured through serum cytokines (Leptin, insulin, adiponectin, RBP4, LCN2, TNFa, IL6, PAI01, FGF21) taken at baseline and 3 months. The changes in these levels will provide information if BZA/CE can improve systematic inflammation.

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Ages Eligible for Study: | 50 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Post-menopausal women (<5y since final menstrual period) with age between 50-60y
- Symptomatic (hot flashes, vaginal dryness) or asymptomatic
- BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
- Fasting glucose <125mg/dl
- Triglycerides <200mg/dl
- Normal mammogram within past 12 months
- Physician clearance
Exclusion Criteria:
- Amenorrhea from other causes (Hyperandrogenemia and anovulation)
- type 2 and type 1 diabetes
- Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
- ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
- Hysterectomy (partial or complete)
- Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237079
United States, Louisiana | |
Tulane University Clinical Translational Unit | |
New Orleans, Louisiana, United States, 70112 |
Principal Investigator: | Franck Mauvais-Jarvis, MD | Tulane University |
Responsible Party: | Franck Mauvais-Jarvis, Professor of Medicine, Tulane University Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT02237079 |
Other Study ID Numbers: |
WI190523 |
First Posted: | September 11, 2014 Key Record Dates |
Last Update Posted: | July 6, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | At this time there is no plan to share IPD |
Bazedoxifene Estrogens Estrogens, Conjugated (USP) Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Bone Density Conservation Agents |