Status:
UNKNOWN
Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Hyperandrogenism
Eligibility:
FEMALE
7-14 years
Phase:
PHASE1
Brief Summary
During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low. However,...
Detailed Description
Studies will be performed in early pubertal (late Tanner 1 \[estradiol level \> 20 pg/ml\] to Tanner 3, premenarcheal) girls with and without hyperandrogenemia (HA). After a potential subject is ident...
Eligibility Criteria
Inclusion
- Female volunteers in early to mid-puberty (i.e., late Tanner I \[estradiol level \> 20 pg/mL\], Tanner II, or Tanner III)
- Premenarcheal
Exclusion
- 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.
Key Trial Info
Start Date :
March 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01428089
Start Date
March 11 2011
End Date
December 1 2024
Last Update
November 2 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States, 22908