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Raising Insulin Sensitivity in Post Menopause (RISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274571
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center

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.


Condition or disease Intervention/treatment Phase
Menopause Drug: TSEC (Tissue-selective estrogen complexes) Other: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Tissue Selective Estrogen Complex to Prevent Metabolic Dysfunction in Women
Actual Study Start Date : September 2015
Actual Primary Completion Date : April 11, 2017
Actual Study Completion Date : April 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: Drug
TSEC (Duavee™, combination of CE and BZA)
Drug: TSEC (Tissue-selective estrogen complexes)
Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)
Other Name: Duavee™

Other: Placebo
non active

Placebo Comparator: Placebo
Non active comparator
Drug: TSEC (Tissue-selective estrogen complexes)
Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)
Other Name: Duavee™

Other: Placebo
non active




Primary Outcome Measures :
  1. 2-step hyperinsulinemic clamp at 90 mg/dl glucose with resting metabolic rate measure [ Time Frame: 8 weeks ]
    Insulin sensitivity by a 2-step hyperinsulinemic euglycemic clamp performed at the end of the two 8-week treatment periods.


Secondary Outcome Measures :
  1. Metabolic rate [ Time Frame: 8 weeks ]
    Metabolic rate step, O2 consumption and CO2 production will be measured by indirect calorimetry for 40 min (last 30 min will be used for calculations) using a metabolic cart (DeltaTrac, SensorMedics,Yorba Linda, CA). Participants will void before the test, and urine will be collected to determine urinary nitrogen and substrate oxidation.

  2. Body Composition [ Time Frame: 8 weeks ]
    DXA and MRS scans will be used for measuring body composition



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274571


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center
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Responsible Party: Eric Ravussin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02274571    
Other Study ID Numbers: PBRC 2014-039
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs