Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01266408
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2010-12-23
Brief Title:
INAS-FOCUS International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study
Sponsor:
Center for Epidemiology and Health Research Germany
Organization:
Center for Epidemiology and Health Research Germany
Study Overview
Official Title:
International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study compares the risks of short- and long-term use of contraceptives containing drospirenone DRSP or dienogest DNGethinylestradiol 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 DNGethinylestradiol 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 DRSPEE plus metafolin and DNGEE 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 DRSPEEmetafolin users of DNGEEmetafolin and users of OCs containing other estrogenprogestogen 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 DRSPEE and the planned third cohort arm users of DNGEE 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 DRSPEE and other OCs containing estrogenprogestogen 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
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 DRSPEEmetafolin users of DNGEEmetafolin and users of OCs containing other estrogenprogestogen 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 DRSPEE and the planned third cohort arm users of DNGEE 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 DRSPEE and other OCs containing estrogenprogestogen 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUPAS1597 | REGISTRY | EUPAS Register | None |
| 15346 | OTHER | None | None |