Pharmacogenetics of Metformin Action in PCOS

What is the purpose of this trial?

Who can participate?

Ages Eligible: 18 Years - 40 Years
Gender Eligible: Female

Inclusion Criteria:

- Premenopausal women between 18-40 years of age and BMI less than 40

- Diagnosed with PCOS as defined by chronic oligo-or amenorrhea (less than 8 menstrual
periods annually); biochemical hyperandrogenemia (elevated total or free
testosterone); normal thyroid function tests and serum prolactin; and exclusion of 21
alpha hydroxylase deficiency by a fasting 17 alpha hydroxyprogesterone less than 200
ng/dl -In acceptable health on the basis of interview, medical history, physical
examination, and laboratory tests (CBC, SMA20,urinanalysis) -Able to provide signed,
witnessed informed consent -Able to comply with study requirements

Exclusion Criteria:

-Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary,
cardiac,renal,hepatic,neurologic,psychiatric,infectious,neoplastic and malignant disease
(other than non-melanoma skin cancer) -Current use of oral contraceptives -seeking
pregnancy; use of fertility drugs within 6 months of study -Current or recent use (within
3 months prior to study entry) of metformin -Documented or suspected recent (within one
year)history of drug abuse or alcoholism -Ingestion of any investigational drug within two
months prior to study onset.

What is the purpose of this trial?

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Who can participate?

Ages Eligible: 18 Years - 40 Years
Gender Eligible: Female

Inclusion Criteria:

- Premenopausal women between 18-40 years of age and BMI less than 40

- Diagnosed with PCOS as defined by chronic oligo-or amenorrhea (less than 8 menstrual
periods annually); biochemical hyperandrogenemia (elevated total or free
testosterone); normal thyroid function tests and serum prolactin; and exclusion of 21
alpha hydroxylase deficiency by a fasting 17 alpha hydroxyprogesterone less than 200
ng/dl -In acceptable health on the basis of interview, medical history, physical
examination, and laboratory tests (CBC, SMA20,urinanalysis) -Able to provide signed,
witnessed informed consent -Able to comply with study requirements

Exclusion Criteria:

-Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary,
cardiac,renal,hepatic,neurologic,psychiatric,infectious,neoplastic and malignant disease
(other than non-melanoma skin cancer) -Current use of oral contraceptives -seeking
pregnancy; use of fertility drugs within 6 months of study -Current or recent use (within
3 months prior to study entry) of metformin -Documented or suspected recent (within one
year)history of drug abuse or alcoholism -Ingestion of any investigational drug within two
months prior to study onset.

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Additional Locations

Virginia