UnknownNot Applicable

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

United States90 participantsStarted 2008-10

Plain-language summary

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.

Who can participate

Age range

8 Years – 15 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) * Abno…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Luteinizing hormone pulse frequency (while awake and while asleep)

Timeframe: Baseline (time zero)

Trial details

NCT IDNCT00930007

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-05

View on ClinicalTrials.gov More Hyperandrogenism trials