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NCT03229408 · ClinicalTrials.gov registry record · Phase 2
Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction
A Phase 2 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT03229408: Completed Phase 2 study, sponsored by University of Illinois at Chicago.
NCT03229408 is a Phase 2 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229408, a Phase 2 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovaries. Insulin resistance (IR) is a common feature of PCOS, and the resultant hyperinsulinemia is theorized to promote hyperandrogenism in the disorder. However, 30-50% of women with PCOS who are lean do not have insulin resistance. Women with PCOS also exhibit chronic low-grade inflammation. In PCOS, glucose ingestion activates nuclear factor ĸB (NFĸB), the cardinal signal of inflammation culminating in upregulation of the inflammation pathway within mononuclear cells (MNC). This phenomenon is independent of excess adiposity and is highly correlated with circulating androgens. In addition, in vitro exposure to proinflammatory stimuli is capable of directly stimulating ovarian theca cell androgen production. Nonacetylated salicylates suppress NFĸB activation and are well tolerated in humans. The proposed research is a randomized double-blind placebo-controlled study of 90 women with PCOS. Forty-five subjects with PCOS (15 lean without IR), 15 lean with IR and 15 obese) receiving salsalate, a nonacetylated salicylate, at an oral dose of 3-4 gm daily for 12 weeks will be compared with 45 age- and body-composition-matched control women with PCOS receiving placebo. The overarching hypothesis is that inflammation contributes to ovarian dysfunction, independent of excess adiposity or IR. The specific aims are, I: To examine the effect of salsalate administration on the ovarian capacity to secrete androgen and on insulin sensitivity in PCOS. II: To examine the effect of salsalate administration on the inflammatory response of mononuclear cells induced by lipid ingestion and glucose infusion in PCOS. The approach involves evaluation of ovarian androgen secretion in response to human chorionic gonadotropin (HCG) administration and insulin sensitivity during the euglycemic phase of a two-step pancreatic clamp along with ovulation monitoring before and after salsalat
Primary Outcome
Data was generated from the post-treatment HCG stimulation test. Area under the curve calculated for serum measurements by chemiluminescence (Siemens Immulite 2000, Cary, NC) from blood samples drawn 0, 24, 48 and 72 hours after HCG administration.
Interventions
- OTHER Placebo
- DRUG Salsalate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 2 |
What the finished NCT03229408 record still lists
NCT03229408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03229408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03229408 about?
NCT03229408 is a clinical study titled "Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction". Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovaries. Insulin resistance (IR) is a common feature of PCOS, and the resultant hyperinsulinemia is theorized to promote hyperandrogenism in the disorder. However, 30-50% of women with PCOS wh...
What is the current status of trial NCT03229408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2018-12-05. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT03229408?
The interventions under investigation include: Placebo (OTHER), Salsalate (DRUG).
Who is sponsoring clinical trial NCT03229408?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03229408's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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