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NCT01109979 · ClinicalTrials.gov registry record · Phase 4
Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT01109979: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01109979 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01109979, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45. The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be randomized at the beginning of the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the first period, and will receive the other medication the second six-weeks of the study. At the very beginning of the study and at the end of each six-week treatment period, subjects will come to the hospital various tests including non-invasive blood vessel imaging tests, blood draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment periods, there will be a four-week medication-free washout period.
Primary Outcome
This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increa
Interventions
- DRUG Estradiol+MPA
- DRUG Estradiol+Drospirenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-12 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
What the finished NCT01109979 record still lists
NCT01109979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Estradiol+MPA is the first listed.
NCT01109979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01109979 about?
NCT01109979 is a clinical study titled "Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function". This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45. The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be...
What is the current status of trial NCT01109979?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2009-12. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01109979?
The interventions under investigation include: Estradiol+MPA (DRUG), Estradiol+Drospirenone (DRUG).
Who is sponsoring clinical trial NCT01109979?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01109979's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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