Metformin Treatment in Polycystic Ovary Syndrome (PCOS)

Description

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.

Study Start Date

July 2014

Estimated Completion Date

December 2020

Interventions

  • Drug: Metformin ER

Specialties

  • Obstetrics & Gynecology: Clinical Pharmacology,General Gynecology
  • Pharmacy: Other Drugs
  • Physician Assistant: Clinical Pharmacology,Obstetrics/Gynecology

MeSH Terms

  • Metformin ER
  • Polycystic Ovary Syndrome

Study ID

Massachusetts General Hospital -- 2014P000911

Status

Recruiting

Trial ID

NCT02198417

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

20

Sponsor

Massachusetts General Hospital

Inclusion Criteria

  • Polycystic ovary syndrome
  • No hormonal or antidiabetic medications for 1 month
  • Good general health

Exclusion Criteria

  • Smoker
  • Acute infection or chronic disease
  • Diabetes
  • Pregnant or trying to get pregnant over next half year
  • Bleeding disorders
  • Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators)

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Cindy Pau MD 617-726-3038 cpau@mgh.harvard.edu

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