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

NCT ID: NCT02237079

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-04-30

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.

Conditions

Obesity; Glucose Homeostasis; Postmenopausal Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bazedoxifene/Conjugated Estrogens (BZA/CE)

Intervention Type: DRUG

Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Daily placebo tablet

Interventions

Bazedoxifene/Conjugated Estrogens (BZA/CE)

Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.

Intervention Type: DRUG

Placebo Oral Tablet

Daily placebo tablet

Intervention Type: DRUG

Other Intervention Names

DUAVEE

Eligibility 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tulane University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Franck Mauvais-Jarvis

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franck Mauvais-Jarvis, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

Tulane University Clinical Translational Unit

New Orleans, Louisiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WI190523

Identifier Type: -

Identifier Source: org_study_id