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Characterization of Metformin Users with Polycystic Ovarian Syndrome: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
metformin
Health Outcome(s)
off-label use in polycystic ovarian syndrome
Description

In this analysis, we assessed the counts of new and prevalent metformin users among women aged 15 to 55 years with diagnosis of polycystic ovarian syndrome (PCOS) from January 1, 2010 through latest available data in the Sentinel Distributed Database (SDD). The overall study period includes data from January 1, 2010 to May 31, 2025. We distributed this request to five Sentinel Data Partners on December 5, 2025. 

This analysis includes two reports:

  • Report 1: Contains the data from the SDD Medicaid dataset. The study period includes data from January 1, 2010 to December 31, 2022.
  • Report 2: Contains combined results from all five Data Partners. The study period includes data from January 1, 2010 to May 31, 2025.
Deliverables (2)
Sentinel Modular Program Report: Characterization of Metformin Users with Polycystic Ovarian Syndrome: A Descriptive Analysis, Report 1 Sentinel Modular Program Report: Characterization of Metformin Users with Polycystic Ovarian Syndrome: A Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2010 - December 31, 2022; January 1, 2010 to May 31, 2025
Analysis Type
Descriptive
Population / Cohort
Females 15 to 55 years of age
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Analysis: Utilization Patterns of Metformin in Patients with Polycystic Ovarian Syndrome: A Descriptive Analysis