Raising Insulin Sensitivity in Post Menopause

NCT02274571 | Completed Early Phase 1 Results

• 1 other identifier: PBRC 2014-039
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (7)

• 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

• Effect of CE/BZA (TSEC) on Fat Cell Ratio (Small/Large)

  8 weeks

• Effect of CE/BZA (TSEC) on Mean Fat Cell Size

  8 weeks

Secondary Outcomes (9)

• Effect of CE/BZA (TSEC) on Fasting Labs

  8 weeks

• Effect of CE/BZA on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp)

  8 weeks

• Effect of CE/BZA (TSEC) on Insulin Sensitivity (by Hyperinsulinemic-Euglycemic Clamp) on FFA

  8 weeks

• Effect of CE/BZA (TSEC) on Resting Metabolic Rate & Substrate Oxidation (by Indirect Calorimetry)

  8 weeks

• Effect of CE/BZA (TSEC) on Resting Metabolic Rate & Substrate Oxidation (by Indirect Calorimetry)

  8 weeks

Study Arms (2)

Drug

EXPERIMENTAL

TSEC (Duavee™, combination of CE and BZA)

Drug: TSEC (Tissue-selective estrogen complexes); Other: Placebo

Placebo

PLACEBO COMPARATOR

Non active comparator

Drug: TSEC (Tissue-selective estrogen complexes); Other: Placebo

Interventions

TSEC (Tissue-selective estrogen complexes) DRUG

Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)

Also known as: Duavee™

Drug; Placebo

Placebo OTHER

non active

Drug; Placebo

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Results Point of Contact

• Title: Dr. Eric Ravussin
• Organization: Pennington Biomedical Research Center

eric.ravussin@pbrc.edu

2252844345

Study Officials

• Eric Ravussin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: September 1, 2015
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-05

Locations

US (1)