Early Phase 1
N=8
Raising Insulin Sensitivity in Post Menopause
Menopause
Bottom Line
View on ClinicalTrials.gov: NCT02274571 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Effect of CE/BZA (TSEC) on Body Composition — 91.3; 90.6; 45.5; 45.7 Kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- TSEC (Tissue-selective estrogen complexes) (Drug); Placebo (Other)
- Age
- Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of CE/BZA (TSEC) on Body Composition |
91.3; 90.6; 45.5; 45.7; 46.0; 45.5 | — |
| PRIMARY Effect of CE/BZA (TSEC) on Ectopic Fat - 1H-MRS, Proton Magnetic Resonance Spectroscopy |
9.00; 8.06; 0.29; 0.36; 0.32; 0.43 | — |
| PRIMARY Effect of CE/BZA (TSEC) on Abdominal Fat Cell Size (by Biopsy) |
66.4; 66.0; 33.6; 34.0 | — |
| PRIMARY Effect of CE/BZA (TSEC) on Body Mass Index |
36.6; 36.4 | — |
| PRIMARY Effect of CE/BZA (TSEC) on Percent Body Fat |
50.9; 51.4 | — |
| PRIMARY Effect of CE/BZA (TSEC) on Fat Cell Ratio (Small/Large) |
2.19; 2.00 | — |
| PRIMARY Effect of CE/BZA (TSEC) on Mean Fat Cell Size |
1.35; 1.6 | — |
| SECONDARY Effect of CE/BZA (TSEC) on Fasting Labs |
105; 102; 179; 187; 138; 156 | — |
| SECONDARY Effect of CE/BZA on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) |
2.83; 2.68; 2.48; 2.55; 11.99; 11.68 | — |
| SECONDARY Effect of CE/BZA (TSEC) on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) on FFA |
0.13; 0.13; 0; 0 | — |
| SECONDARY Effect of CE/BZA (TSEC) on Resting Metabolic Rate & Substrate Oxidation (by Indirect Calorimetry) |
0.81; 0.80; 0.85; 0.83; 0.92; 0.91 | — |
| SECONDARY Effect of CE/BZA (TSEC) on Resting Metabolic Rate & Substrate Oxidation (by Indirect Calorimetry) |
0.81; 0.80; 0.85; 0.83; 0.92; 0.91 | — |
| SECONDARY Effect of CE/BZA (TSEC) on Fasting Insulin |
16.6; 15.7 | — |
| SECONDARY Effect of CE/BZA (TSEC) on Fasting Free Fatty Acids |
0.72; 0.78 | — |
| SECONDARY Effect of CE/BZA on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) on Glucose |
90; 88; 97; 95 | — |
| SECONDARY Effect of CE/BZA (TSEC) on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) on Insulin |
37.8; 34.8; 250.8; 259.8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02274571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.