Raising Insulin Sensitivity in Post Menopause

• Status: Completed
• Trial end date: 2017-04-11
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to find out if a novel drug approved by the Food and Drug Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by decreasing body fat especially in your liver.

DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of postmenopausal women, the use of estrogens alone can increase the risk of developing cancer of the uterus. So estrogens have been traditionally paired with a progestin to decrease the risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place of a progestin to help protect the uterus against thickening of the uterus that may result from estrogens alone.

In this study, you will get either DUAVEE™ or the placebo (a "dummy pill" that may look like medicine but contains no active medication) first and then switch to the other pill.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pennington Biomedical Research Center
• Treatments: Estrogens

Criteria

Inclusion Criteria:

• Post-menopausal women (<5y post last period)

• Age between 50-60y

• Symptomatic (hot flashes, vaginal dryness) or asymptomatic

• BMI 30-40 kg/m2

• Normal mammogram past 12 months

• Physician clearance (Ob/Gyn or PBRC)

Exclusion Criteria:

• Amenorrhea other causes (excess androgen)

• Diabetes mellitus

• Medications: diabetes, antidepressant uncontrolled depression (2 months stability on SSRIs are fine), antipsychotics, oral steroids, weight loss drugs

• Tricyclic antidepressants (TCAs)

• ≤ 3 month washout of birth control pill, estrogen, and/or progestin

• Hysterectomy (total or partial)

• Contraindications to estrogen treatment

• Unable or unwilling to do an MRS