Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents

Completed · Phase 2/Phase 3

Conditions studied: PCOS

In brief

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.

Key facts

Study ID

NCT03981861

Run by

Children's Mercy Hospital Kansas City

People needed

12

Starts

2016-07-02

Expected to finish

2019-06-05

Last updated by the study team

2021-02-23

Who can join

Age: 13 and older, up to 21. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Children's Mercy Hospital — Kansas City, Missouri, 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.