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Adrenal Hyperplasia Among Young People With PCOS

NCT01313455 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2019-05-31

No results posted yet for this study

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Maya B Lodish, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
16 Years
Max Age
29 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-10
Completion
2017-10-24

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01313455 on ClinicalTrials.gov