Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents

• Status: Completed
• Trial end date: 2019-06-05
• Target enrollment: 0
• Participant gender: Female

Summary

To exam in the effect of a combination of low dose Metformin and Spironolactone on functional brain MRI, menstrual regulation and metabolism in adolescents with PCOS.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Treatments: Metformin; Spironolactone

Criteria

Inclusion Criteria:

• Generally healthy

• Meeting Androgen Excess Society (AES) diagnostic criteria of PCOS: Menstrual Dysfunction or PCO ovaries on ultrasound AND clinical or biochemical hyperandrogenism

• Normal liver and kidney function

• No chronic illnesses except for stable, treated hypothyroidism

Exclusion Criteria:

• Use of metformin and/or spironolactone within the last 6 months

• Currently on either oral hormonal contraception or other forms of hormonal contraception such as Depo-Provera, NuvaRing

• Current or past pregnancy

• Currently sexually active

• Psychiatric disorder based on self/parental report

• Type 2 diabetes (blood glucose > 200mg/dl on OGTT)

• Anemia (Hct < 35)

• Impaired kidney function (Baseline creatinine > 1.0 mg)

• Abnormal liver transaminases > 2 x the upper limit of normal range

• Potassium elevated outside the reference range (in non-hemolyzed blood sample)