NCT01422096

Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hyperandrogenemia
• Obesity
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Leuprolide	depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if \> 37.5 kg im once

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2011-08-23
• Last updated: 2018-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study