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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 is a Phase 2 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 60 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03229408
The ClinicalTrials.gov registry entry for NCT03229408 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03229408 reports 0 study locations.
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.
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