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Biguanide

Metformin for Polycystic Ovary Syndrome

Phase < 1

Recruiting

Led By Christine Burt Solorzano, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Overweight females (>85th BMI%)

Be younger than 65 years old

Must not have

Morning cortisol < 3 µg/dL or history of Cushing syndrome or adrenal insufficiency

Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c ≥6.5%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial will test whether the drug metformin can lower androgen levels in overweight pubertal girls with androgen excess.

Who is the study for?

This trial is for overweight pubertal girls aged 7-18 with excess male hormones, specifically those who are in the early to late stages of puberty and have higher than normal free testosterone levels. Participants must not be pregnant, lactating, diabetic, or have certain hormonal disorders.

What is being tested?

The study tests if metformin can reduce androgen overproduction in these girls. It involves a 12-week treatment period where insulin sensitivity is expected to improve and subsequently lower androgen levels after specific hormone stimulation tests.

What are the potential side effects?

While not explicitly listed here, common side effects of metformin include stomach upset or discomfort, diarrhea, nausea or vomiting; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a female and my BMI is above the 85th percentile.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My morning cortisol is low or I have had Cushing syndrome or adrenal issues.

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I have diabetes or my blood sugar or A1c levels are high.

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My BMI is below the 5th percentile for my age.

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I have a history of congenital adrenal hyperplasia or my 17-hydroxyprogesterone levels are above 300 ng/dL.

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My DHEAS levels are higher than normal for my age.

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My thyroid hormone levels are not normal for my age.

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I am either younger than 7 or older than 18 years old.

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I have a serious heart or lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: metforminExperimental Treatment1 Intervention

12 weeks metformin, with pre- and post- dexamethasone and ACTH to perform standardized adrenal stimulation testing; dexamethasone and rhCG to perform standardized ovarian stimulation testing

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

FDA approved

0 / 9Eligibility criteria met