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Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone (CRM005)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930007
First Posted: June 30, 2009
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Chris McCartney, University of Virginia
  Purpose
The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone pulse frequency are different in early pubertal girls with high testosterone levels compared to early pubertal girls with normal testosterone levels.

Condition Intervention
Hyperandrogenism Other: Blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia

Resource links provided by NLM:


Further study details as provided by Chris McCartney, University of Virginia:

Primary Outcome Measures:
  • Luteinizing hormone pulse frequency (while awake and while asleep) [ Time Frame: Baseline (time zero) ]

Secondary Outcome Measures:
  • 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
Serum obtained during frequent sampling will be stored (in case repeat measurements are required), but will be discarded at the end of the study

Estimated Enrollment: 90
Study Start Date: October 2008
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:
During early puberty, luteinizing hormone (LH) pulse frequency normally increases during sleep. In contrast, preliminary data suggest that obese girls (who have high testosterone levels in general) demonstrate low LH frequency during the day and night during early puberty; but at mid puberty rapidly transition to a high LH frequency during the day and night. We hypothesize that in early pubertal girls with high testosterone levels, overnight increases of LH frequency are less prominent than those observed in early pubertal girls with normal testosterone levels. We will assess this using a frequent sampling protocol for assessment of LH pulse frequency (with sampling occurring while awake and while asleep) in early pubertal girls with and without high testosterone levels. Sleep will be formally evaluated.
  Eligibility

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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
Study Population
Community sample and patients from local clinics
Criteria

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)
  • 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)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Christopher R McCartney, MD University of Virginia
  More Information

Responsible Party: Chris McCartney, Associate Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT00930007     History of Changes
Other Study ID Numbers: 13950
First Submitted: June 24, 2009
First Posted: June 30, 2009
Last Update Posted: February 23, 2017
Last Verified: February 2017
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

Keywords provided by Chris McCartney, University of Virginia:
Luteinizing hormone
Puberty

Additional relevant MeSH terms:
Hyperandrogenism
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Hormones
Testosterone
Methyltestosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents


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