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NCT01489319 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)
A Phase 1 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT01489319: Clinical Trial Phase 1 study, sponsored by Indiana University.
NCT01489319 is a Phase 1 study that was terminated before completion, run by Indiana University. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01489319, a Phase 1 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the relationship between lipid-induced inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine the effect of salsalate and polygonum cuspidatum extract (PCE) containing resveratrol on lipid-induced inflammation, ovarian androgen secretion, body composition and ovulation in a subset of normal weight women with PCOS.
Primary Outcome
This outcome along with insulin sensitivity derived from an oral glucose tolerance test (OGTT) and body composition measured by dual energy absorptiometry (DEXA) will be assessed in all study subjects (PCOS and controls).
Interventions
- DRUG Salsalate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Why NCT01489319 stopped before completion
NCT01489319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 1 intervention - of which Salsalate is the first listed.
NCT01489319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01489319 about?
NCT01489319 is a clinical study titled "Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)". The purpose of this study is to determine the relationship between lipid-induced inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine the effect of salsalate and polygonum cuspidatum extract (PCE) containing resveratrol on lipid-induced inflammat...
What is the current status of trial NCT01489319?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2012-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01489319?
The interventions under investigation include: Salsalate (DRUG).
Who is sponsoring clinical trial NCT01489319?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01489319's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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