Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone (CRM005)
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ClinicalTrials.gov Identifier: NCT00930007 |
Recruitment Status :
Active, not recruiting
First Posted : June 30, 2009
Last Update Posted : October 14, 2020
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Condition or disease | Intervention/treatment |
---|---|
Hyperandrogenism | Other: Blood sampling |
Study Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia |
Study Start Date : | October 2008 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | July 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Hyperandrogenemic
Girls with elevated free testosterone concentrations
|
Other: Blood sampling
Blood sampling for later hormone measurements |
Controls
Girls with normal free testosterone concentrations
|
Other: Blood sampling
Blood sampling for later hormone measurements |
- Luteinizing hormone pulse frequency (while awake and while asleep) [ Time Frame: Baseline (time zero) ]
- Progesterone concentration [ Time Frame: Baseline (time zero) ]
- Estradiol concentration [ Time Frame: Baseline (time zero) ]
- Testosterone concentrations [ Time Frame: Baseline (time zero) ]
- Luteinizing hormone amplitude [ Time Frame: Baseline (time zero) ]
- Sleep stage parameters [ Time Frame: Baseline (time zero) ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 8 Years to 15 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Early to midpubertal girls (late Tanner 1 [i.e., estradiol > 20 pg/ml] to Tanner 3)
- Premenarcheal
- Approximate ages, 8-15 years
Exclusion Criteria:
- BMI-for-age < 5th percentile
- Inability to comprehend what will be done during the study or why it will be done
- Being a study of GnRH pulse regulation in adolescent girls with and without HA, boys are excluded
- Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome, leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.
- Pregnancy or lactation
- Virilization
- Total testosterone > 150 ng/dl (confirmed on repeat)
- DHEAS > upper limit of age-appropriate normal range (confirmed on repeat) (mild elevations may be seen in adolescent HA, and elevations < 1.5 times the age-appropriate upper limit of normal will be accepted in such girls)
- Follicular phase 17-hydroxyprogesterone > 250 ng/dl (for girls < 12 years old) or > 300 ng/dl (for girls 12 and older) (confirmed on repeat), which suggests the possibility of congenital adrenal hyperplasia. NOTE: If an elevated follicular 17-hydroxyprogesterone is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for study participation
- History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before age 8)
- A previous diagnosis of diabetes
- Fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c > 6.5% (confirmed on repeat)
- Abnormal TSH (confirmed on repeat) (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded)
- Abnormal prolactin (confirmed on repeat) (mild elevations may be seen in HA girls, and elevations < 1.5 times the upper limit of normal will be accepted in this group)
- Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired growth in children, striae)
- Hematocrit < 36% and hemoglobin < 12 g/dl (confirmed on repeat)
- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
- Persistent liver test abnormalities (confirmed on repeat), with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome
- Persistently abnormal sodium, potassium, or elevated creatinine concentration (confirmed on repeat)
- Bicarbonate concentrations < 20 or > 30 (confirmed on repeat)
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No medications known to affect the reproductive system, glucose metabolism, lipid metabolism, or blood pressure can be taken in the 3 months prior to the first inpatient GCRC study (or in the 2 months prior to screening)
- Such medications include oral contraceptive pills, progestins, metformin, glucocorticoids, psychotropics, and sympathomimetics/stimulants (e.g., methylphenidate)
- Patients taking restricted medications will be excluded unless written permission (for the subjects to discontinue the medication) is received from the subject's physician
- Weight < 22 kg is an absolute exclusion criterion (to ensure safe blood withdrawal)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930007
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Christopher R McCartney, MD | University of Virginia |
Responsible Party: | Chris McCartney, Associate Professor of Medicine, University of Virginia |
ClinicalTrials.gov Identifier: | NCT00930007 |
Other Study ID Numbers: |
13950 |
First Posted: | June 30, 2009 Key Record Dates |
Last Update Posted: | October 14, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | We do not have current plans to share IPD |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Luteinizing hormone Puberty |
Hyperandrogenism 46, XX Disorders of Sex Development Disorders of Sex Development Urogenital Abnormalities |
Adrenogenital Syndrome Congenital Abnormalities Gonadal Disorders Endocrine System Diseases |