Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362479
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2006-08-09
Brief Title:
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Prospective Multicenter Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
Status:
COMPLETED
Status Verified Date:
2013-08
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 6 months of oral contraceptive therapy with DR-1021 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:
The overall study duration for each patient will be approximately 8 months which includes a screening period of approximately 4 weeks a treatment period of approximately six months six28-day cycles and a follow-up visit approximately 4 weeks 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