Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-02 @ 9:32 PM
Study NCT ID:
NCT00477633
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Safety and Efficacy of an Oral Contraceptive
Sponsor:
Warner Chilcott
Organization:
Study Overview
Official Title:
An Open Label Study of the Contraceptive Efficacy of Norethindrone 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:
False
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?: