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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
Sponsor:
Information provided by (Responsible Party):
Franck Mauvais-Jarvis, Tulane University Health Sciences Center

Study Description
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Brief Summary:
The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.

Condition or disease Intervention/treatment Phase
Obesity Glucose Homeostasis Postmenopausal Symptoms Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE) Drug: Placebo Oral Tablet Phase 4

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Drug: Placebo Oral Tablet
Daily placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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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


Locations
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United States, Louisiana
Tulane University Clinical Translational Unit
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
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Principal Investigator: Franck Mauvais-Jarvis, MD Tulane University
More Information
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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
Additional relevant MeSH terms:
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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