check_circleStudy Completed

Contraception

Bayer Identifier:

15346

ClinicalTrials.gov Identifier:

NCT01266408

EudraCT Number:

Not Available

EU CT Number:

Not Available
INAS-FOCUS International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study

Trial 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).

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - 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

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

Trial summary

Enrollment Goal
82921
Trial Dates
November 2010 - October 2019
Phase
N/A
Could I Receive a placebo
N/A
Products
BEYAZ (EE20/DRSP/L-5-MTHF, BAY98-7071)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many locations, Canada
Completed
Many locations, Russia
Completed
Many locations, Ukraine
Completed
Many locations, United States

Primary Outcome

  • Absolute risk of venous thromboembolic events
    date_rangeTime Frame:
    Up to 6 years
  • Absolute risk of acute myocardial infarction
    date_rangeTime Frame:
    Up to 6 years
  • Absolute risk of cerebrovascular accidents
    date_rangeTime Frame:
    Up to 6 years

Secondary Outcome

  • Colorectal cancer
    date_rangeTime Frame:
    Up to 6 years
  • Other cancer entities
    date_rangeTime Frame:
    Up to 6 years

Trial design

INAS-FOCUS International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study
Trial Type
Observational
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A