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

Tulane University Health Sciences Center

Status and phase: Completed; Phase 4

Conditions: Obesity; Postmenopausal Symptoms; Glucose Homeostasis

Treatments: Drug: Placebo Oral Tablet; Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)

Study type: Interventional

Funder types: Other

Identifiers

NCT02237079

WI190523

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

17 participants in 2 patient groups, including a placebo group

Bazedoxifene/Conjugated Estrogens (BZA/CE)

Experimental group

Description:

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.

Treatment:

Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Oral Tablet