Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

Launched by UNIVERSITY OF VIRGINIA · Sep 1, 2011

Keywords

ClinConnect Summary

This clinical trial is studying how the hormone progesterone affects the levels of another hormone called luteinizing hormone (LH) in girls who are starting to go through puberty. Researchers want to find out if giving small doses of progesterone can help reduce the nighttime increase of LH pulses, which is something that happens naturally during puberty. They are also looking at whether having high levels of testosterone in the blood interferes with progesterone's ability to do this. By understanding these hormone changes better, the researchers hope to learn more about how normal menstrual cycles begin in girls and how to address any issues that might arise during puberty.

To be eligible for the study, girls between the ages of 10 and 13 who are in early to mid-puberty and have not yet had their first period can participate. However, girls who are pregnant or have certain health conditions, like high testosterone levels or significant heart or lung problems, cannot join. If selected, participants will receive three small doses of progesterone and will be closely monitored during the study. This research is important because it may help improve our understanding of puberty and related health concerns in young girls.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female volunteers in early to mid-puberty (i.e., late Tanner I \[estradiol level \> 20 pg/mL\], Tanner II, or Tanner III)
• • Premenarcheal
• Exclusion Criteria:
• • Pregnancy
• • Inability to comprehend what will be done during the study or why it will be done
• • Hemoglobin less than 12 g/dl and hematocrit less than 36%
• • 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 thyroid-stimulating hormone (TSH) values
• • Total testosterone \> 200 ng/dl
• • Basal (follicular) 17-hydroxyprogesterone \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
• • Dehydroepiandrosterone sulfate (DHEA-S) \> 800 mcg/dl
• • Elevation of prolactin \> 2 times upper limit of normal
• • Weight less than 26 kg.