Adrenal Hyperplasia Among Young People With PCOS

NCT01313455 | Completed

• 2 other identifiers: 11011911-CH-0119
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adrenal Hyperplasia; Polycystic Ovarian Syndrome; Oligomenorrhea; Obesity; Hyperandrogenism

Keywords

Oligomenorrhea; Adrenal Hyperplasia; Obesity; Hyperandrogenism; Polycystic Ovarian Syndrome; PCOS; Polycystic Ovary; Healthy Volunteer; HV

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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-acanthosis nigricans syndrome; Fasting insulin levels are obtained to rule out syndromes of severe insulin resistance and hyperandrogenism; if insulin is above 80 mU/mL in the fasting state, and/or \>300 mU/mL following a 2- or 3-hour oral glucose tolerance test (obtained elsewhere), patients are not eligible.
• Women with prior history of pregnancy.
• Young women with hyperandrogenemia, hirsutism or known adrenal tumors or other endocrine diseases, patients on multiple medications, known insulin resistance, or any other chronic or acute illness are not eligible as controls for this study.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Rosenfield RL. What every physician should know about polycystic ovary syndrome. Dermatol Ther. 2008 Sep-Oct;21(5):354-61. doi: 10.1111/j.1529-8019.2008.00217.x.

  PMID: 18844713 BACKGROUND

• Karch S, Manzambi ZA, Salaun JJ. Field trials with Vectolex (Bacillus sphaericus) and Vectobac (Bacillus thuringiensis (H-14)) against Anopheles gambiae and Culex quinquefasciatus breeding in Zaire. J Am Mosq Control Assoc. 1991 Jun;7(2):176-9.

  PMID: 1895075 BACKGROUND

• Krone N, Arlt W. Genetics of congenital adrenal hyperplasia. Best Pract Res Clin Endocrinol Metab. 2009 Apr;23(2):181-92. doi: 10.1016/j.beem.2008.10.014.

  PMID: 19500762 BACKGROUND

• Gourgari E, Lodish M, Keil M, Sinaii N, Turkbey E, Lyssikatos C, Nesterova M, de la Luz Sierra M, Xekouki P, Khurana D, Ten S, Dobs A, Stratakis CA. Bilateral Adrenal Hyperplasia as a Possible Mechanism for Hyperandrogenism in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2016 Sep;101(9):3353-60. doi: 10.1210/jc.2015-4019. Epub 2016 Jun 23.

  PMID: 27336356 DERIVED

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital; Polycystic Ovary Syndrome; Oligomenorrhea; Obesity; Hyperandrogenism

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; 46, XX Disorders of Sex Development

Study Officials

• Maya B Lodish, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 11, 2011
• Study Start: March 10, 2011
• Study Completion: October 24, 2017
• Last Updated: May 31, 2019

Record last verified: 2017-10-24

Locations

US (1)