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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 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
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
780 Previous Clinical Trials
1,315,530 Total Patients Enrolled
19 Trials studying Obesity
2,478 Patients Enrolled for Obesity
Christine Burt Solorzano, MDPrincipal Investigator - University of Virginia
UVA Child Development & Rehabilitation Center, University of Virginia Medical Center
University Of Virginia School Of Medicine (Medical School)
Children'S Hosp Of L A (Residency)
7 Previous Clinical Trials
275 Total Patients Enrolled
5 Trials studying Obesity
219 Patients Enrolled for Obesity

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT01422746 — Phase < 1
Obesity Research Study Groups: metformin
Obesity Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT01422746 — Phase < 1
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01422746 — Phase < 1
~0 spots leftby Dec 2024
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