CompletedNot Applicable

Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)

United States37 participantsStarted 2006-10

Plain-language summary

The purpose of this study is to determine if insulin resistance (how well the body uses insulin and clears sugar) can affect cortisol levels in normal healthy women and women with polycystic ovary syndrome of all body weights.

Who can participate

Age range

18 Years – 45 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.

Inclusion Criteria (Healthy controls): * Healthy * At lifetime maximal weight * Weight stable for at least 6 months prior to study entry * Willing to commit to not making significant changes to their diet or daily activities while enrolled. * Premenopausal * Have regular menstrual cycles * No evidence of hirsutism Additional Inclusion Criteria (Subjects with PCOS): * Clinical findings of amenorrhea or oligomenorrhea dating from menarche * Clinical and/or biochemical evidence of hyperandrogenism * Exclusion of related disorders Exclusion Criteria (Healthy controls): * Less than 18 years of age * Exercise \> 30 minutes/day, 3 times a week * Smokers * Heavy alcohol drinkers (\> 2 drinks/day) * Type 2 diabetes * Medical diagnoses including heart disease and cancer * Psychiatric illness (i.e.depression, psychosis, bipolar, schizophrenia) * Body weight \> 136 kg * Pregnant * Endocrine diseases affecting body composition or androgen levels Additional Exclusion Criteria (Subjects with PCOS): * Laboratory evidence of hyperprolactinemia, thyroid dysfunction, or 21-hydroxylase-deficient nonclassic CAH * Contraindication to pioglitazone (i.e. CHF, impaired liver function, anemia, depressed leukocyte counts, pulmonary disease, known sensitivity to thiazolidinediones.

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

The comparison of body surface area adjusted cortisol production rate (CPR/BSA) before insulin sensitizing therapy in women with PCOS.

Timeframe: Before 6 months of insulin sensitizing therapy

The comparison of body surface area adjusted cortisol production rate (CPR/BSA) after insulin sensitizing therapy in women with PCOS.

Timeframe: After 6 months of insulin sensitizing therapy

Trial details

NCT IDNCT00694759

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Polycystic Ovary Syndrome trials