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NCT01313455 · ClinicalTrials.gov registry record

Adrenal Hyperplasia Among Young People With PCOS

A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
96
Enrollment target

NCT01313455 is a clinical trial that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 96 participants.

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The verdict

NCT01313455 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
96 participants
Enrollment target

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.

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2011-03-10
Est. Completion 2017-10-24

What the Registry Record Tells You About NCT01313455

The ClinicalTrials.gov registry entry for NCT01313455 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01313455 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01313455 about?

NCT01313455 is a clinical study titled "Adrenal Hyperplasia Among Young People With PCOS". 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 re...

What is the current status of trial NCT01313455?

This trial is currently completed. The enrollment target is 96 participants. The study started on 2011-03-10. Estimated completion is 2017-10-24.

Who is sponsoring clinical trial NCT01313455?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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