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NCT01427595 · ClinicalTrials.gov registry record · NA

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

A NA study, sponsored by University of Virginia.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT01427595 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 25 participants.

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The verdict

NCT01427595, a NA study, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

Many, but not all, girls with high levels of the male hormone testosterone go on to develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of difficulty becoming pregnant. The investigators do not understand why some girls with high hormones develop PCOS and others do not. In a previous study by our group, some girls with high levels of male hormones had abnormalities in the secretion of another hormone, called luteinizing hormone (LH), that are often seen in women with PCOS. However, another group had normal LH secretion. The girls with the abnormal LH secretion had higher levels of another hormone, called insulin, than the girls with normal LH secretion. The investigators will test whether metformin, an insulin-sensitizing agent, changes the effects of high male hormone levels in adolescent girls, specifically by looking at their LH secretion response following metformin treatment.

Interventions

  • DRUG Metformin
  • DRUG Progesterone
  • DRUG estrace

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2009-02-18
Est. Completion 2015-01-17
Phase NA

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT01427595

The ClinicalTrials.gov registry entry for NCT01427595 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.

NCT01427595 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01427595 about?

NCT01427595 is a clinical study titled "Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone". Many, but not all, girls with high levels of the male hormone testosterone go on to develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of difficulty becoming pregnant. ...

What is the current status of trial NCT01427595?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2009-02-18. Estimated completion is 2015-01-17.

What interventions are being tested in trial NCT01427595?

The interventions under investigation include: Metformin (DRUG), Progesterone (DRUG), estrace (DRUG).

Who is sponsoring clinical trial NCT01427595?

This trial is sponsored by University of Virginia, which has 449 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.