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NCT00203996 · ClinicalTrials.gov registry record · Phase 4
Polycystic Ovary Syndrome (PCOS) and Sleep Apnea
A Phase 4 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT00203996 is a Phase 4 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 37 participants.
The verdict
NCT00203996, a Phase 4 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject populations. Women with PCOS are more insulin resistant than weight-matched control women and have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes, as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has not been evaluated. The overall objective of the proposed study is to analyze the direction of causality between sleep disturbances and markers of the metabolic syndrome in PCOS.
Interventions
- DEVICE continuous positive airway pressure (CPAP)
- DRUG pioglitazone
- DRUG depot leuprolide plus estrogen/progestin replacement
- PROCEDURE REM frag
- PROCEDURE SWS supp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2003-09 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00203996
The ClinicalTrials.gov registry entry for NCT00203996 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which continuous positive airway pressure (CPAP) is the first listed.
NCT00203996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00203996 about?
NCT00203996 is a clinical study titled "Polycystic Ovary Syndrome (PCOS) and Sleep Apnea". Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome,...
What is the current status of trial NCT00203996?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2003-09. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00203996?
The interventions under investigation include: continuous positive airway pressure (CPAP) (DEVICE), pioglitazone (DRUG), depot leuprolide plus estrogen/progestin replacement (DRUG), REM frag (PROCEDURE), SWS supp (PROCEDURE).
Who is sponsoring clinical trial NCT00203996?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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