Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394771
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2006-10-30
Brief Title:
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Prospective Multicenter Double-Blinded Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen
Status:
COMPLETED
Status Verified Date:
2013-07
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:
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive 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:
This Phase 2 prospective multicenter double-blinded randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive
Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups
The overall study duration will be approximately 9 months this will include a screening period of approximately 4 weeks a run-in period of 4 weeks a treatment period of approximately 6 months two91-day cycles and a final study visit occurring 14-21 days after completion of study drug
Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups
The overall study duration will be approximately 9 months this will include a screening period of approximately 4 weeks a run-in period of 4 weeks a treatment period of approximately 6 months two91-day cycles and a final study visit occurring 14-21 days after completion of study drug
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