Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone (CRM005)
Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
A observational or N/A phase clinical study on Hyperandrogenism, this trial is ongoing. The trial is conducted by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and has accumulated 15 data snapshots since 2008. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
15 versions recorded-
Jan 2026 — Present [monthly]
Unknown
-
Sep 2024 — Present [monthly]
Unknown
-
Jul 2024 — Sep 2024 [monthly]
Unknown
Status: Unknown Status → Unknown
-
Jun 2024 — Jul 2024 [monthly]
Unknown Status
Status: Active Not Recruiting → Unknown Status
-
Jun 2022 — Jun 2024 [monthly]
Active Not Recruiting
▶ Show 10 earlier versions
-
Dec 2021 — Jun 2022 [monthly]
Active Not Recruiting
-
Jan 2021 — Dec 2021 [monthly]
Active Not Recruiting
-
Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting
-
Nov 2019 — Nov 2020 [monthly]
Active Not Recruiting
-
Jun 2018 — Nov 2019 [monthly]
Active Not Recruiting
-
May 2018 — Jun 2018 [monthly]
Active Not Recruiting
-
Apr 2018 — May 2018 [monthly]
Active Not Recruiting
Phase: NA → None
-
Aug 2017 — Apr 2018 [monthly]
Active Not Recruiting NA
-
Mar 2017 — Aug 2017 [monthly]
Active Not Recruiting NA
-
Jan 2017 — Mar 2017 [monthly]
Active Not Recruiting NA
First recorded
Oct 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- University of Virginia
For direct contact, visit the study record on ClinicalTrials.gov .