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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is assessing the efficacy of metformin for hepatic fat in adolescents and young adults with polycystic ovary syndrome (PCOS). PCOS is a common condition that frequently presents in adolescence and young adulthood, and is associated with insulin resistance, NAFLD, and lipid abnormalities. Metformin is an insulin sensitizing medication that is widely used to treat type 2 diabetes mellitus, and may have beneficial effects on PCOS and 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.Check my eligibility

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.See study design

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 below

Select...

I started my periods at least 2 years ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Fatty acid glycerol esters

Insulin Resistance

The association of percentage liver fat with M30, a hepatic apoptosis marker

+4 more

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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,787 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

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT02500147 — Phase 4

Polycystic Ovary Syndrome Research Study Groups: Metformin, Placebo

Polycystic Ovary Syndrome Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT02500147 — Phase 4

Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02500147 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions on participation in this trial?

"This study is accepting participants aged between 13 and 25."

Answered by AI

Has Metformin received formal authorization from the FDA?

"The safety of Metformin is highly regarded, so it earned a score of 3. This medication has been approved after undergoing four different stages of clinical trials."

Answered by AI

Could I participate in this experiment?

"Patients aged 13 to 25 years old with sclerocystic ovaries can apply for this medical trial, which is seeking a total of 46 participants."

Answered by AI

In what ways is Metformin commonly employed therapeutically?

"Metformin is widely prescribed to manage the effects of physical activity, and it also has applications for treating type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Have there been previous trials conducted on the efficacy of Metformin?

"At present, Metformin is the subject of 170 clinical trials worldwide with 43 in the final stages. Pittsburgh, Pennsylvania houses most of these studies; however, 1903 sites are hosting research into this medication globally."

Answered by AI

What is the current size of this research cohort?

"At present, this study is not recruiting participants. Initially posted on September 8th 2011 and most recently edited on July 19th 2022, it appears to be inactive for the time being. However, there are still 1857 trials open for sclerocystic ovaries and 170 studies involving Metformin that are actively seeking patients."

Answered by AI

Is the enrollment of participants for this experiment still open?

"Unfortunately, this medical research is not presently open to new participants. It was released on September 8th 2011 and updated lastly on July 19 2022. However, there are 1,857 clinical trials actively recruiting patients with sclerocystic ovaries and 170 related studies focusing on Metformin looking for volunteers right now."

Answered by AI

Recent research and studies

Fertility and SterilityJournal

Metabolic Manifestations of Polycystic Ovary Syndrome in Nonobese Adolescents: Retinol-binding Protein 4 and Ectopic Fat Deposition

Sopher, Aviva B., Adrienne T. Gerken, William S. Blaner, Jeremy M. Root, Donald J. McMahon, and Sharon E. Oberfield. 2012. “Metabolic Manifestations of Polycystic Ovary Syndrome in Nonobese Adolescents: Retinol-binding Protein 4 and Ectopic Fat Deposition”. Fertility and Sterility. Elsevier BV. doi:10.1016/j.fertnstert.2012.01.111.

Journal of Pediatric Endocrinology and MetabolismJournal

Anti-mullerian Hormone May Be a Useful Adjunct in the Diagnosis of Polycystic Ovary Syndrome in Nonobese Adolescents

Sopher, Aviva B., Galina Grigoriev, Diana Laura, Tamara Cameo, Jodi P. Lerner, R. Jeffrey Chang, Donald J. McMahon, and Sharon E. Oberfield. 2014. “Anti-mullerian Hormone May Be a Useful Adjunct in the Diagnosis of Polycystic Ovary Syndrome in Nonobese Adolescents”. Journal of Pediatric Endocrinology and Metabolism. Walter de Gruyter GmbH. doi:10.1515/jpem-2014-0128.

Journal of Pediatric Endocrinology and MetabolismJournal

Anti-mullerian Hormone May Be a Useful Adjunct in the Diagnosis of Polycystic Ovary Syndrome in Nonobese Adolescents

Fertility and SterilityJournal

Metabolic Manifestations of Polycystic Ovary Syndrome in Nonobese Adolescents: Retinol-binding Protein 4 and Ectopic Fat Deposition