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Biguanide
Metformin for Polycystic Ovary Syndrome
Phase 4
Waitlist Available
Led By Aviva B Sopher, MD, MS, MS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 2 years postmenarche
Be younger than 65 years old
Must not have
Any diseases affecting bone metabolism (collagen disorders, primary hyperparathyroidism, nephrolithiasis, untreated hyperthyroidism), indwelling hardware
Nonclassical congenital adrenal hyperplasia (CAH) - early morning 17-hydroxyprogesterone level less than 200 ng/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing metformin, a common diabetes medication, to see if it can reduce liver fat in young people with polycystic ovary syndrome (PCOS). The study focuses on adolescents and young adults who have high liver fat and are at risk for non-alcoholic fatty liver disease (NAFLD). Metformin works by helping the body use insulin more effectively, which may lower liver fat. Metformin is an antidiabetic drug widely used to improve insulin resistance and has shown potential benefits in treating non-alcoholic fatty liver disease (NAFLD).
Who is the study for?
This trial is for healthy girls and young women aged 13-25 with PCOS, diagnosed by NIH criteria. They should have signs of high male hormones or irregular periods but no other health issues affecting metabolism, no recent hormonal contraceptives or metformin use, and not be pregnant.
What is being tested?
The study tests if Metformin can reduce liver fat in young females with PCOS compared to a placebo. It's a double-blind trial where neither participants nor researchers know who gets Metformin or the placebo until the end of the study.
What are the potential side effects?
Metformin may cause digestive upset like nausea, diarrhea, stomach pain; it might also lead to vitamin B12 deficiency over time. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I started my periods at least 2 years ago.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have conditions like collagen disorders or untreated thyroid issues affecting my bones.
Select...
My early morning 17-hydroxyprogesterone level is below 200 ng/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in percentage liver fat between Metformin arm and Placebo arm in adolescents and young adults with PCOS and with elevated percentage liver fat (>/=4.8%)
Secondary study objectives
Fatty acid glycerol esters
Insulin Resistance
The association of percentage liver fat with M30, a hepatic apoptosis marker
+4 moreSide 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
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
Adolescents and young adults with PCOS and liver fat greater than or equal to 4.8% will be randomized to metformin or placebo. Metformin ER (extended release) will be administered as two pills of 500 mg each. For the first week subjects will take one pill orally on a daily basis and thereafter will take two pills orally on a daily basis. The intervention will last six months.
Group II: PlaceboPlacebo Group1 Intervention
Adolescents and young adults with PCOS and liver fat greater than or equal to 4.8% will be randomized to metformin or placebo. Subjects randomized to placebo will be instructed to take one pill daily by mouth for one week and then to take one pill daily by mouth for the remainder of six months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Polycystic Ovary Syndrome (PCOS) include insulin sensitizers like Metformin, which work by improving the body's sensitivity to insulin. This is crucial for PCOS patients as insulin resistance is a common feature of the condition, leading to elevated insulin levels that can exacerbate hyperandrogenism (high levels of male hormones) and menstrual irregularities.
By enhancing insulin sensitivity, Metformin helps to lower insulin and androgen levels, thereby improving ovulatory function and reducing symptoms such as hirsutism and acne. This mechanism is particularly important for managing the metabolic and reproductive abnormalities associated with PCOS.
Metformin and polycystic ovary syndrome.
Metformin and polycystic ovary syndrome.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,482 Previous Clinical Trials
2,629,905 Total Patients Enrolled
2 Trials studying Polycystic Ovary Syndrome
81 Patients Enrolled for Polycystic Ovary Syndrome
Aviva B Sopher, MD, MS, MSPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have conditions like collagen disorders or untreated thyroid issues affecting my bones.You are currently pregnant or have been pregnant in the past.I have high male hormone levels or symptoms, irregular periods, and no other known disorders.I am a healthy female aged between 13 and 25.I have used hormonal contraceptives or metformin in the last 3 months.I have a condition or take medication that affects my body's hormone levels.PCOS will be diagnosed using specific criteria from 1990 set by the National Institutes of Health (NIH).My early morning 17-hydroxyprogesterone level is below 200 ng/dL.I started my periods at least 2 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Metformin
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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