TerminatedPhase 1

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

Stopped: The PI left Indiana University. The findings served as preliminary data for a recently awarded NIH R01 grant.

United States47 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

General Inclusion Criteria: * Acceptable health based on interview, medical history, physical examination, and lab tests * Ability to comply with the requirements of the study * Ability and willingness to provide signed, witnessed informed consent Inclusion Criteria for PCOS: * Between the ages of 18-40 years * Body mass index between 18 and 25, or between 30 and 40 * Less than or equal to 8 periods annually * An elevated serum androgen level or skin manifestations of androgen excess * Normal thyroid function tests and normal prolactin level * Exclusion of late-onset adrenal hyperplasia Inclusion Criteria for Ovulatory Controls: * Between the ages of 18-40 years * Body mass index between 18 and 25, or between 30 and 40 * Normal regular monthly periods * No clinical evidence of androgen excess * No evidence of polycystic ovaries on ultrasound Exclusion Criteria: * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

White blood cell nuclear factor kappa B (NFkappaB) activation in response to oral lipid ingestion and ovarian androgen secretion in response to human chorionic gonadotropin (HCG) stimulation.

Timeframe: 3 years

Trial details

NCT IDNCT01489319

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Polycystic Ovary Syndrome trials