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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: Completed NA study, sponsored by University of Virginia.
NCT01427595 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The progesterone (P4) sensitivity index is defined as the percent change in 11-hour LH pulse frequency before and after P4 and estradiol administration for 7 days, divided by the day 7 mean serum P4 concentration. We compared the P4 sensitivity index after metformin administration to the baseline P4 sensitivity index, using Wilcoxon signed-rank test.
Interventions
- DRUG Metformin
- DRUG Progesterone
- DRUG estrace
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-02-18 |
| Est. Completion | 2015-01-17 |
| Phase | NA |
What the finished NCT01427595 record still lists
NCT01427595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT01427595 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01427595's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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