Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196326
Status:
COMPLETED
Last Update Posted:
2016-11-16
First Post:
2005-09-12
Brief Title:
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle Low Dose Combination Oral Contraceptive
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multicenter Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle Low Dose Combination Oral Contraceptive Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle
Status:
COMPLETED
Status Verified Date:
2016-09
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 is an open-label single treatment study All subjects will receive one year of oral contraceptive therapy with DR-1011 Study participants will receive physical and gynecological exams including Pap smear During the study all participants will be required to complete a diary
Detailed Description:
None
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