Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391807
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2006-10-20
Brief Title:
Study of Safety and Efficacy of an Oral Contraceptive
Sponsor:
Warner Chilcott
Organization:
Warner Chilcott
Study Overview
Official Title:
Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol
Status:
COMPLETED
Status Verified Date:
2013-04
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 is a non-comparative study The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy The secondary objectives are to assess the incidence of intracyclic bleeding and to assess the safety and tolerability of the product
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