What this trial studies
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.
Conditions in scope
- Menopause
Interventions
- TSEC (Tissue-selective estrogen complexes) (Drug) — Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)
- Placebo (Other) — non active
Who can join
Women only · Ages 50 Years to 60 Years · Accepts healthy volunteers.
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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Baton Rouge | Louisiana | Pennington Biomedical Research Center | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: EARLY_PHASE1
- Start date: 2015-09
- Primary completion: 2017-04-11
- Last update posted: 2025-06-04
- First posted: 2014-10-24
Sponsor & contact
Lead sponsor: Pennington Biomedical Research Center (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Effect of CE/BZA (TSEC) on Body Composition (8 weeks)
- Effect of CE/BZA (TSEC) on Ectopic Fat - 1H-MRS, Proton Magnetic Resonance Spectroscopy (8 weeks)
- Effect of CE/BZA (TSEC) on Abdominal Fat Cell Size (by Biopsy) (8 weeks)
- Effect of CE/BZA (TSEC) on Body Mass Index (8 weeks)
- Effect of CE/BZA (TSEC) on Percent Body Fat (8 weeks)
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT02274571 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.