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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: Completed study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2011-03-10 |
| Est. Completion | 2017-10-24 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT01313455 record still lists
NCT01313455 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 96 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01313455 does not publish any study locations in the registry export this page uses.
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.
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