Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Withdrawn before enrolling · Early Phase 1
Conditions studied: Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
In brief
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).
Key facts
- Study ID
- NCT01422096
- Run by
- University of Virginia
- People needed
- 0
- Starts
- 2018-06-01
- Expected to finish
- 2018-07-17
- Last updated by the study team
- 2018-07-19
Who can join
Age: 7 and older, up to 18. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Virginia Center for Research in Reproduction — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.