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INAS-FOCUS

INAS-FOCUS

Objective

Status

Enrolling

Condition
Contraception

Description

Study comparing risks of contraceptive use.  INAS-FOCUS (International Active Surveillance Study-Folate in Oral Contraceptives Utilization Study)

Purpose

Compare the risks of short and long term use of contraceptives containing drospirenone (DRSP) or dienogest (DNG/ehtinylestrdiol (EE) plus levomefolate calcium with the risks of short and long-term use of other established oral contraceptives (OCs)

Phase
Observational

Key Inclusion Criteria

Women who are using oral contraceptives:

  • first starting (first-ever users) oral contraceptives
  • switchers (switching her current contraception to a new oral contraceptive without a break in between)
  • restarters (women with a pill intake break)

Key Exclusion Criteria

  • Long term users
  • Women who do not agree to participate
  • Women with a language barrier

ClinicalTrials.gov Identifier

NCT01266408

IRB Protocol Number
ZEG2010_02
Principal Investigator(s)
Earl Brewster, MD
Michael Brown, MD

Clinical Trial Categories

  • Obstetrics/Gynecology
Sponsor(s)
Bayer-Schering Pharma AG
ZEG- Berlin Center for Epidemiology and Health Research, Germany
Contact
Renee Hendrickson, RN CCRC at 701-780-1694
or rhendrickson@altru.org