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Trial record 60 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

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

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ClinicalTrials.gov Identifier: NCT01266408
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

Tracking Information
First Submitted Date December 23, 2010
First Posted Date December 24, 2010
Last Update Posted Date October 9, 2019
Actual Study Start Date November 22, 2010
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2018)
  • Absolute risk of Venous Thromboembolic Events [ Time Frame: Within 6 years ]
  • Absolute risk of Acute Myocardial Infarction [ Time Frame: Within 6 years ]
  • Absolute risk of Cerebrovascular Accidents [ Time Frame: Within 6 years ]
Original Primary Outcome Measures
 (submitted: December 23, 2010)
  • Cardiovascular events [ Time Frame: Within 6 years ]
  • Cancer [ Time Frame: Within 15 years ]
Change History Complete list of historical versions of study NCT01266408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 9, 2018)
  • Colorectal cancer [ Time Frame: Within 6 years ]
  • Other cancer entities [ Time Frame: Within 6 years ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title INAS-FOCUS (International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study)
Official Title International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study
Brief Summary 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).
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.

Amendment, approved by the Safety Monitoring and Advisory Council on 13th May 2018:

During study recruitment, only one combined oral contraceptive was launched containing metafolin (DRSP/EE+) and the planned third cohort arm (users of DNG/EE+) was rendered obsolete.

In addition, early recruitment rates and exposure figures in INAS-FOCUS suggested that the study would be inadequately powered to accurately assess the risk of colorectal cancer at 15 years. Interim reports were presented to the Safety Monitoring and Advisory Council (SMAC) and in consultation with the funder, a decision made to discontinue INAS-FOCUS following analysis of cardiovascular events (Part 1 of study). The current protocol reflects the developments discussed above. The original three cohorts have been reduced to two (DRSP/EE+ and other OCs containing estrogen/progestogen) and Part II (long-term assessment of risk of colorectal cancer) has been removed from the protocol. Colorectal cancer outcomes will be analyzed as a secondary outcome for signal detection purposes only.

For historical accuracy and context, the introduction and background sections of the protocol have been left unchanged.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women using oral contraceptives
Condition Contraception
Intervention Not Provided
Study Groups/Cohorts
  • DRSP/EE/metafolin
    Women using oral contraceptives containing drospirenone, ethinylestradiol and metafolin
  • Other OC users
    Women using oral contraceptives containing other estrogen/progestogen combinations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 23, 2019)
82921
Original Estimated Enrollment
 (submitted: December 23, 2010)
80000
Study Completion Date Not Provided
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01266408
Other Study ID Numbers ZEG2010_02
15346 ( Other Identifier: Bayer AG )
EUPAS1597 ( Registry Identifier: EUPAS Register )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Study Sponsor Center for Epidemiology and Health Research, Germany
Collaborators Bayer
Investigators
Principal Investigator: Juergen C Dinger, PhD, MD Center for Epidemiology and Health Research
PRS Account Center for Epidemiology and Health Research, Germany
Verification Date October 2019