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Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM) (BIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 26, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • Body composition [ Time Frame: Change at 3 months from baseline ]
  • Glucose Homeostasis [ Time Frame: Change at 3 months from baseline ]
    IV Glucose Tolerance Test
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Official Title  ICMJE Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Glucose Homeostasis
  • Postmenopausal Symptoms
Intervention  ICMJE
  • Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)
    Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
    Other Name: DUAVEE
  • Drug: Placebo Oral Tablet
    Daily placebo tablet
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)
  • 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.
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2018)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2014)
20
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02237079
Other Study ID Numbers  ICMJE WI190523
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: At this time there is no plan to share IPD
Current Responsible Party Franck Mauvais-Jarvis, Tulane University Health Sciences Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tulane University Health Sciences Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franck Mauvais-Jarvis, MD Tulane University
PRS Account Tulane University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP