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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: Clinical Trial Phase 4 study, sponsored by University of Chicago.
NCT00203996 is a Phase 4 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Apnea-hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.
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 |
Why NCT00203996 stopped before completion
NCT00203996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which continuous positive airway pressure (CPAP) is the first listed.
NCT00203996 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00203996's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 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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