Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)

Stopped early · Phase 1

Conditions studied: Polycystic Ovary Syndrome

In brief

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.

Key facts

Study ID

NCT01489319

Run by

Indiana University

People needed

47

Starts

2012-02-01

Expected to finish

2015-06-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Diabetes mellitus
• Clinically significant pulmonary, cardiac ,renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
• High blood pressure
• Current or recent (within 6 weeks prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, thiazolidinediones, glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone, flutamide, etc)
• Documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism
• Tobacco smoking if salsalate or PCE will be administered
• Ingestion of any investigational drugs within 4 weeks prior to study onset
• Pregnancy or lactation (less than or equal to 6 weeks postpartum)

Where it is running

• Indiana University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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