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| ID | Type | Description | Link |
|---|---|---|---|
| P50HD028934 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Hormones are substances that are made by the body and are sent directly out into the bloodstream to increase or decrease the function of certain organs, glands, or other hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too much testosterone in their blood. Too much testosterone in the blood can possibly lead to a problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual periods, excess facial and body hair, and too much testosterone in their blood. On the other hand, some girls with too much testosterone in their blood do not develop PCOS. We do not know why some of these girls develop PCOS and why some do not. The purpose of this research study is to find out whether too much testosterone can cause problems with other hormones that can lead to the development of PCOS. This study may help us understand more about the causes of PCOS.
Polycystic ovary syndrome (PCOS) is a common disorder marked by irregular ovulation and hyperandrogenism. Hyperandrogenemia during adolescence can be a forerunner of adult PCOS. However, the progression of hormonal abnormalities leading to PCOS are unclear. We will examine hormonal profiles (e.g., LH, FSH, progesterone, testosterone, estradiol) during pubertal maturation in adolescent girls with and without elevated plasma androgens. The working hypothesis is that, in pubertal girls without hyperandrogenemia, overnight rises of progesterone are associated with a reduction of LH frequency during the waking morning hours. However, in pubertal girls with hyperandrogenemia, LH frequency will be higher than normal during both the day and night, despite similar or higher progesterone levels. The studies will involve frequent blood sampling over 18 hours. We will assess differences in hormone parameters between time blocks (1900-2300 h, 2300-0300 h, 0300-0700 h, 0700-1100 h) in individuals to evaluate day-night changes. We will compare such changes between those with hyperandrogenemia and those without hyperandrogenemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperandrogenemia | Peripubertal girls with hyperandrogenemia |
| |
| Controls | Peripubertal girls without hyperandrogenemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Blood sampling for later hormone measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean LH frequency when awake (19:00-23:00 and 07:00-11:00) and when asleep (23:00-07:00) in girls with and without hyperandrogenemia | Time frame for the study will be 18 hours (Sampling begins at 1800 hrs and proceeds through 1200 hours the following day). |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime (awake) and nighttime (sleep) differences in hormones (LH, FSH, T, E2, P, and cortisol) in girls with and without hyperandrogenemia | Time frame for the study will be 18 hours (Sampling begins at 1800 hrs and proceeds through 1200 hours the following day). |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescent females
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Gilrain | Contact | 434-243-6911 | pcos@virginia.edu | |
| Christopher R. McCartney, MD | Contact | 434-243-6911 | cm2hq@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher R. McCartney, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research in Reproduction, University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
We do not have current plans to share IPD
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| ID | Term |
|---|---|
| D017588 | Hyperandrogenism |
| ID | Term |
|---|---|
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum Urine
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |