Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
Conditions
Brief summary
This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).
Interventions
DRUGLeuprolide
depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if \> 37.5 kg im once
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* overweight (\>85th BMI%) females * Early to late puberty (expected age range 7-18) * Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage) * Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Exclusion criteria
* Screening labs outside of age-appropriate normal range * Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.) * Morning Cortisol \<5 g/dL * 17-hydroxyprogesterone \>295 ng/dL * History of Cushing's syndrome or adrenal insufficiency * Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration | 4 weeks after leuprolide |
Secondary
| Measure | Time frame |
|---|---|
| Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration | 4 weeks after leuprolide |
Countries
United States
Outcome results
None listed