INAS-FOCUS (International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study)

This study is currently recruiting participants.
Verified January 2014 by Center for Epidemiology and Health Research, Germany
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT01266408
First received: December 23, 2010
Last updated: January 23, 2014
Last verified: January 2014

December 23, 2010
January 23, 2014
October 2010
November 2025   (final data collection date for primary outcome measure)
  • Cardiovascular events [ Time Frame: Within 6 years ] [ Designated as safety issue: Yes ]
  • Cancer [ Time Frame: Within 15 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01266408 on ClinicalTrials.gov Archive Site
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INAS-FOCUS (International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study)
International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study

The study compares the risks of short- and long-term use of contraceptives containing drospirenone (DRSP) or dienogest (DNG)/ethinylestradiol (EE) plus levomefolate calcium (metafolin) with the risks of short- and long-term use of other established oral contraceptives (OCs).

New oral contraceptives (OCs) containing drospirenone (DRSP) or dienogest (DNG)/ethinylestradiol (EE) plus levomefolate calcium (metafolin) have been recently introduced and will be introduced in a number of countries in the near future. Although the safety of OCs has improved over the last 50 years with reductions in the estrogen and progestogen dose, special attention regarding oral contraceptive safety amongst women with risk factors for venous and arterial thromboembolism as well as cancer is necessary. Folic acid supplementation has been implicated in both the prevention and the promotion of several cancers, including colorectal cancer (CRC). Chronic folate deficiency seems to be associated with colorectal carcinogenesis, while high folic acid levels may have a tumor-promoting effect. On balance an oral contraceptive containing folate may be advantageous for several reasons. It may increase baseline folate levels with potential for protecting against some malignancies and concurrently decrease the risk of neural tube defects in women who become pregnant due to OC-failure, incorrect OC-use or after stopping the OC for a planned pregnancy. Although unexpected, it is unclear whether combined oral contraceptives plus metafolin in general and specifically DRSP/EE plus metafolin and DNG/EE plus metafolin will alter the risk profile of established oral contraceptives.

This study investigates the safety of these new oral contraceptives with regard to cardiovascular outcomes and colorectal cancer.

INAS-FOCUS is a prospective, controlled, non-interventional cohort study with three study arms: users of DRSP/EE/metafolin, users of DNG/EE/metafolin and users of OCs containing other estrogen/progestogen combinations. The users will be grouped to starters (first-ever users), switchers (women switching OC without a pill intake break) and restarters (women with a pill intake break). Users of an OC are accrued by a network of prescribing physicians. Baseline and follow-up information is collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Women using oral contraceptives

Contraception
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  • DRSP/EE/metafolin
    Women using oral contraceptives containing drospirenone, ethinylestradiol and metafolin
  • DNG/EE/metafolin
    Women using oral contraceptives containing dienogest, ethinylestradiol and metafolin
  • Other OC users
    Women using oral contraceptives containing other estrogen/progestogen combinations
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80000
December 2025
November 2025   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women starting OC use ("starters")
  • Women switching OC use without a pill intake break ("switchers")
  • Women restarting OC use after a pill intake break ("restarters")
  • Women willing to participate in the active surveillance

Exclusion Criteria:

  • Long-term users
  • Women who do not agree to participate
  • Women with a language barrier
Female
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Yes
Contact: Suzanne Reed, MSc, PhD +49 30 945 101 63 reed@zeg-berlin.de
Contact: Klaas Heinemann, PhD, MD, MBA +49 30 945 101 24 k.heinemann@zeg-berlin.de
Germany
 
NCT01266408
ZEG2010_02
Yes
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Center for Epidemiology and Health Research, Germany
Bayer
Principal Investigator: Juergen C Dinger, PhD, MD Center for Epidemiology and Health Research
Center for Epidemiology and Health Research, Germany
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP