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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after metformin administration
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a female and my BMI is above the 85th percentile.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after metformin administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after metformin administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in free testosterone or 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after metformin administration for 12 weeks
Secondary outcome measures
Changes in adrenal and ovarian steroid precursors after ACTH and rhCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of metformin administration
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
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
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
760 Previous Clinical Trials
1,250,406 Total Patients Enrolled
17 Trials studying Obesity
2,512 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
4 Trials studying Obesity
184 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My morning cortisol is low or I have had Cushing syndrome or adrenal issues.I have diabetes or my blood sugar or A1c levels are high.Unusually high levels of prolactin in the body.My BMI is below the 5th percentile for my age.You are pregnant or breastfeeding.I have a history of congenital adrenal hyperplasia or my 17-hydroxyprogesterone levels are above 300 ng/dL.My blood tests are normal for my age, except for slightly low red blood cell count.Your total testosterone level is higher than 150 ng/dL.Showing masculine traits or characteristics.My DHEAS levels are higher than normal for my age.Your blood has low levels of red blood cells and hemoglobin.My thyroid hormone levels are not normal for my age.Your levels of sodium, potassium, or bicarbonate, or your creatinine level are not within the normal range.You have ongoing liver test problems.I am a female and my BMI is above the 85th percentile.Your lab test results are not normal, and this has been confirmed by doing the test again.You have high levels of a hormone called testosterone.I am either younger than 7 or older than 18 years old.I haven't taken any medication that affects fertility or blood sugar in the last 3 months.I have a serious heart or lung condition.I am between 7 and 18 years old, experiencing puberty.
Research Study Groups:
This trial has the following groups:- Group 1: metformin
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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