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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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).


Condition
Contraception

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study

Resource links provided by NLM:


Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Cardiovascular events [ Time Frame: Within 6 years ] [ Designated as safety issue: Yes ]
  • Cancer [ Time Frame: Within 15 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80000
Study Start Date: October 2010
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women using oral contraceptives

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266408

Contacts
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

Locations
Germany
Center for Epidemiology and Health Research Recruiting
Berlin, Germany, 10115
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   
Principal Investigator: Juergen C Dinger, PhD, MD         
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
Principal Investigator: Juergen C Dinger, PhD, MD Center for Epidemiology and Health Research
  More Information

No publications provided

Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01266408     History of Changes
Other Study ID Numbers: ZEG2010_02
Study First Received: December 23, 2010
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Epidemiology and Health Research, Germany:
Drospirenone
Dienogest
Metafolin
Folic acid
Safety

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Drospirenone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014