Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196352
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2005-09-12
Brief Title:
A Multicenter Study to Evaluate the Safety of Seasonique an Oral Contraceptive
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Prospective Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive Seasonique Which Utilizes Ethinyl Estradiol During the Pill-free Interval
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive with ethinyl estradiol supplementation during the usual hormone-free week for up to an additional three consecutive years
Detailed Description:
This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive with ethinyl estradiol supplementation during the usual hormone-free week for up to an additional three consecutive years This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety Only patients enrolled in the earlier trial are eligible for participation
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