Examining hormone levels in girls during puberty
Assessment of Day-night Secretion of Progesterone and LH Across Pubertal Maturation in Girls With and Without Hyperandrogenemia (JCM023)
This study looks at hormone levels in girls going through puberty to see how those with higher testosterone might be different from those with normal levels and how this could relate to developing polycystic ovary syndrome (PCOS).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT02155933 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the hormonal profiles of adolescent girls during puberty, focusing on those with and without elevated testosterone levels. It aims to understand the relationship between hormone secretion patterns, specifically progesterone and LH, and the potential development of polycystic ovary syndrome (PCOS). The study involves frequent blood sampling over an 18-hour period to assess day-night variations in hormone levels. By comparing hormonal changes between girls with hyperandrogenemia and those with normal androgen levels, the research seeks to clarify the hormonal mechanisms that may lead to PCOS.
Who should consider this trial
Good fit: Ideal candidates for this study are early and late pubertal girls aged 7 years and older, both with normal androgens and those with hyperandrogenemia.
Not a fit: Patients who are pregnant or have significant underlying health conditions that affect hormone levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the hormonal causes of PCOS, potentially leading to better prevention and treatment strategies for affected individuals.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated that hormonal profiling can provide valuable insights into conditions like PCOS.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- Center for Research in Reproduction, University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Christopher R. McCartney, MD — University of Virginia
- Study coordinator: Melissa Gilrain
- Email: pcos@virginia.edu
- Phone: 434-243-6911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.