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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: Completed Early Phase 1 study, sponsored by Pennington Biomedical Research Center.
NCT02274571 is a Early Phase 1 study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02274571 record still lists
NCT02274571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02274571 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02274571's enrollment target sits among peer trials
8 1782nd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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