Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319163
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2006-04-26
Brief Title:
Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mgEthinyl Estradiol 20 mg LNGEE in Healthy Cycling Women
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
An Open-label Single-dose Randomized 2-period Crossover Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mgEthinyl Estradiol 20 mg LNGEE in Healthy Cycling Women
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNGEE
Secondary Objective To obtain additional safety and tolerability data concerning LNGEE in healthy cycling women
Secondary Objective To obtain additional safety and tolerability data concerning LNGEE in healthy cycling women
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