Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02155933
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2014-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Day-night Secretion of Progesterone and LH Across Puberty
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Assessment of Day-night Secretion of Progesterone and LH Across Pubertal Maturation in Girls With and Without Hyperandrogenemia (JCM023)
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LH
Brief Summary:
Hormones are substances that are made by the body and are sent directly out into the bloodstream to increase or decrease the function of certain organs, glands, or other hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too much testosterone in their blood. Too much testosterone in the blood can possibly lead to a problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual periods, excess facial and body hair, and too much testosterone in their blood. On the other hand, some girls with too much testosterone in their blood do not develop PCOS. We do not know why some of these girls develop PCOS and why some do not. The purpose of this research study is to find out whether too much testosterone can cause problems with other hormones that can lead to the development of PCOS. This study may help us understand more about the causes of PCOS.
Detailed Description:
Polycystic ovary syndrome (PCOS) is a common disorder marked by irregular ovulation and hyperandrogenism. Hyperandrogenemia during adolescence can be a forerunner of adult PCOS. However, the progression of hormonal abnormalities leading to PCOS are unclear. We will examine hormonal profiles (e.g., LH, FSH, progesterone, testosterone, estradiol) during pubertal maturation in adolescent girls with and without elevated plasma androgens. The working hypothesis is that, in pubertal girls without hyperandrogenemia, overnight rises of progesterone are associated with a reduction of LH frequency during the waking morning hours. However, in pubertal girls with hyperandrogenemia, LH frequency will be higher than normal during both the day and night, despite similar or higher progesterone levels. The studies will involve frequent blood sampling over 18 hours. We will assess differences in hormone parameters between time blocks (1900-2300 h, 2300-0300 h, 0300-0700 h, 0700-1100 h) in individuals to evaluate day-night changes. We will compare such changes between those with hyperandrogenemia and those without hyperandrogenemia.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P50HD028934 | NIH | None | https://reporter.nih.gov/quic… | View |