Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testo… (NCT00930007) | Clinical Trial Compass
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 range8 Years – 15 Years
SexFEMALE
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…
What they're measuring
1
Luteinizing hormone pulse frequency (while awake and while asleep)