NCT01422746

Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess

Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess (CBS005)

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether metformin administration can ameliorate androgen (male hormone) overproduction in overweight pubertal girls with androgen excess. The investigators hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration will improve androgen levels after adrenal stimulation testing with adrenocorticotropic hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).

Conditions

• Obesity
• Hyperandrogenemia
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Metformin	500-1000 mg PO BID (X12 weeks)

Timeline

• Start date: 2017-03-20
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2011-08-24
• Last updated: 2023-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study