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NCT02274571 · ClinicalTrials.gov registry record · Early Phase 1
Raising Insulin Sensitivity in Post Menopause
A Early Phase 1 study, sponsored by Pennington Biomedical Research Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT02274571 is a Early Phase 1 study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 8 participants.
The verdict
NCT02274571, a Early Phase 1 study, has completed, sponsored by Pennington Biomedical Research Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG TSEC (Tissue-selective estrogen complexes)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-04-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02274571
The ClinicalTrials.gov registry entry for NCT02274571 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pennington Biomedical Research Center, which has 258 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02274571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02274571 about?
NCT02274571 is a clinical study titled "Raising Insulin Sensitivity in Post Menopause". 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...
What is the current status of trial NCT02274571?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2015-09. Estimated completion is 2017-04-11.
What interventions are being tested in trial NCT02274571?
The interventions under investigation include: Placebo (OTHER), TSEC (Tissue-selective estrogen complexes) (DRUG).
Who is sponsoring clinical trial NCT02274571?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
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