Assessment of Day-night Secretion of Progesterone and LH Across Puberty

Launched by UNIVERSITY OF VIRGINIA · Jun 2, 2014

Keywords

ClinConnect Summary

This clinical trial is studying how hormone levels, specifically progesterone and luteinizing hormone (LH), change during puberty in girls. The researchers want to understand the relationship between high levels of testosterone and conditions like polycystic ovary syndrome (PCOS), which can cause irregular periods and unwanted hair growth. By looking at how these hormones behave during different stages of puberty, the study aims to uncover why some girls with high testosterone develop PCOS while others do not.

The trial is currently recruiting girls aged 7 to 20 who are going through puberty, whether they have normal hormone levels or elevated testosterone. To participate, girls should not be pregnant or have certain health issues, such as significant heart or lung problems. Participants will have their hormone levels monitored, and this research could help improve our understanding of hormonal changes during puberty and the development of PCOS. If you're interested or think you might qualify, it’s a great opportunity to contribute to important medical research.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Early and late pubertal girls with normal androgens
• • Early and late pubertal girls with hyperandrogenemia
• • All subjects will be girls from pre-puberty (Stage 1 breast development and pubic hair growth but at least 7 years old) to 7 years post menarche.
• Exclusion Criteria:
• • Pregnancy
• • Inability to comprehend what will be done during the study or why it will be done
• • Hemoglobin \<11.5 g/dL for non-African American subjects; Hemoglobin \< 11.0 g/dL for African American subjects
• • Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)
• • Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)
• • Total bilirubin \> 1.5 times upper limit of normal (i.e., confirmed on repeat)
• • Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
• • Untreated hypo- or hyperthyroidism (reflected by persistently abnormal TSH values)
• • Total testosterone \> 200 ng/dl
• • Basal (follicular) 17-OHP \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
• • DHEA-S \> 800 mcg/dl
• • Elevation of prolactin \> 2 times upper limit of normal
• • Weight less than 25 kg