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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 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 24 participants.

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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.

Interventions

  • DRUG Estradiol+MPA
  • DRUG Estradiol+Drospirenone

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-12
Est. Completion 2016-06
Phase Phase 4

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT01109979

The ClinicalTrials.gov registry entry for NCT01109979 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Estradiol+MPA is the first listed.

NCT01109979 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.