Metformin Treatment in Polycystic Ovary Syndrome (PCOS)

Status Active, not recruiting

Clinical Trial Summary

PCOS occurs when a woman does not release an egg regularly each month, causing her periods to be irregular. Women with PCOS can also have increased hair growth on the face and body, acne, head balding, infertility, pre-diabetes, and diabetes. PCOS is commonly treated with oral contraceptive pills (also known as the birth control pills). Sometimes, a medication called metformin is also used to treat PCOS, especially if a woman has evidence of insulin resistance or if fertility is desired. Unfortunately, metformin works in only some women with PCOS. The mechanism through which metformin works in PCOS is not clear and it difficult to predict who will benefit from metformin treatment and who will not.

The investigators are doing this research study to look at how the medication metformin affects the cells in the body of patients with PCOS. Specifically, the investigators will look at how metformin affects the mitochondria. Mitochondria are the part of cells that produce fuel (energy) for other cells and play a role in metabolism. The investigators would like to see whether there is a relationship between mitochondrial activity and symptoms of polycystic ovary syndrome (PCOS) before and after treatment with metformin. They would also like to study whether genes affect the response to metformin in women with PCOS.

Clinical Trial Description

Women who are eligible to enroll in this study will be treated with the medication metformin for 12 weeks. Before and after treatment with metformin, the following will be assessed:

- Weight, blood pressure, waist circumference

- Lipids (cholesterol)

- Hormone levels (including testosterone and other androgens)

- IV glucose tolerance test (to assess for early evidence of insulin resistance)

- Effect of metformin on muscle mitochondria (this will involve one MRI scan and one muscle biopsy each before and after treatment with metformin)

Ovulation will be closely monitored at least twice a month with pelvic ultrasounds and blood tests for estrogen and progesterone levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02198417
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 2014
Completion date	December 2020

View Details

See also
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Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
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Active, not recruiting	`NCT03043924` - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT05246306` - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
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Completed	`NCT05029492` - Effect of Visceral Manipulation on PCOS	N/A
Not yet recruiting	`NCT02255578` - Endobarrier Treatment in Women With PCOS	Phase 3
Completed	`NCT02924025` - Motivational Interviewing as an Intervention for PCOS	N/A
Not yet recruiting	`NCT00883259` - Metformin and Gestational Diabetes in High-risk Patients: a RCTs	Phase 4
Withdrawn	`NCT01638988` - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin	Phase 3
Completed	`NCT02098668` - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON	N/A
Completed	`NCT01462864` - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome	N/A
Recruiting	`NCT01431352` - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT00989781` - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.