Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. We propose that improving insulin sensitivity with use of Metformin in women diagnosed with PCOS has facilitatory influences on the uterine endometrium.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Metformin; Progesterone

Criteria

Inclusion Criteria:

• Premenopausal between 18-42 years of age

• Diagnosed with PCOS as defined by chronic oligo- or amenorrhea (8 menstrual periods annually); biochemical hyperandrogenemia (elevated total or free testosterone) and /or clinical hyperandrogenism (excessive facial hair &/or acne); exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone <200 ng/dl).

• Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months

• Able to provide signed informed consent

• Able to comply with study requirements

• Willing to delay the start of clinically prescribed metformin treatment

Exclusion Criteria:

• Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer)

• Current use of hormonal contraceptives

• Seeking pregnancy; use of fertility drugs within 6 months of study

• Current or recent (within 3 months) use of metformin

• Ingestion of any investigational drug within two months prior to study onset

• Evidence of endometrial hyperplasia or cancer upon baseline EMBx