CompletedNot Applicable

Adrenal Hyperplasia Among Young People With PCOS

United States96 participantsStarted 2011-03-10

Plain-language summary

Background: \- Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the secretion of certain hormones, which can lead to reproductive and other issues in women. Frequent complications of PCOS include irregular menstruation, development of ovarian cysts, and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in the production of certain hormones and the regulation of steroid levels in the blood, and may be affected in women with PCOS. Researchers are interested in studying possible connections between the adrenal glands and PCOS in young women who have been diagnosed with PCOS and healthy volunteers with normal menstrual function. Objectives: \- To investigate possible connections between adrenal gland steroid hormone secretion and polycystic ovarian syndrome. Eligibility: * Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are healthy volunteers with normal menstrual function. * Participants must be willing to discontinue the use of oral contraceptives or any other medications that alter steroid hormone production for at least 1 month before the start of the study. Design: * Participants will be screened with a physical examination, medical history, and blood and urine tests. All participants will also have a pelvic (ovarian) ultrasound. * All participants will be admitted to the hospital for a 1-week testing period, which will involve the following tests: * Regular blood draws for two 2-hour periods (late evening and early morning) to measure hormone levels * Fasting blood draws with a dose of corticotropin to test the body's adrenal function * Hormone level measurement following regular doses of dexamethasone (a drug that controls the function of the adrenal gland) * Daily urine collection for 6 days. * Other studies, such as imaging studies of the adrenal glands, may be conducted as required by the study researchers.

Who can participate

Age range16 Years – 29 Years

SexFEMALE

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

* INCLUSION CRITERIA FOR PATIENTS: Women 16-24 years old with PCOS defined as biochemical hyperandrogenism with associated findings of either menstrual irregularity and /or polycystic ovaries on ultrasound; hyperandrogenism defined as elevation of any of the following androgens: free testosterone, total testosterone, DHEAS, DHEA, 17 0H progesterone, androstenedione, 17OH pregnenolone; a polycystic ovary on ultrasound should either have 12 follicles measuring 2-9 mm in diameter, or have an increased ovarian volume of 10 CC or greater; menstrual irregularity defined as: Amenorrhea refers to absence of bleeding for at least three usual cycle lengths; oligomenorrhea refers to bleeding that occurs at an interval greater than 35 days. We would like patients to have oligomenorrhea for at least six usual cycle lengths. Patients have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study INCLUSION CRITERIA FOR CONTROLS: Women 18-25 years old with normal menstrual function; they have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study. EXCLUSION CRITERIA FOR PATIENTS: Patients who have hyperandrogenism due to 21 hydroxylase deficiency non- classic adrenal hyperplasia androgen secreting neoplasms Women with known or suspected androgenic/anabolic drug use Women with severe insulin resistance-acanth…

Trial details

NCT IDNCT01313455

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sponsor typeNIH

Study typeOBSERVATIONAL