Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185224
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2005-09-10
Brief Title:
Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Single-center Open-label Controlled Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive SH T00658ID as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel SH D00264A on Plasma Lipids Hemostatic Variables and Carbohydrate Metabolism in Healthy Female Volunteers Aged 18-50 Years Over 7 Treatment Cycles Including the Pharmacokinetics
Status:
COMPLETED
Status Verified Date:
2011-07
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:
The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids hemostatic variables and carbohydrate metabolism In addition the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed
Detailed Description:
The study has previously been posted by Schering AG Germany Schering AG Germany has been renamed to Bayer Schering Pharma AG GermanyBayer Schering Pharma AG Germany is the sponsor of the trial
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 301886 | None | None | None |
| EudraCT 2004-001614-13 | None | None | None |