Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185380
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2005-09-13
Brief Title:
Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System LCS
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Multi-center Open Randomized Dose Finding Phase II Study to Investigate Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems LCS Releasing Different Amounts of Levonorgestrel Compared to MIRENA in Nulliparous and Parous Women in Need of Contraception
Status:
COMPLETED
Status Verified Date:
2015-05
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 investigate if drug doses lower than the one released from Mirena would be as effective for contraception as Mirena Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems IUSs The IUSs are nearly alike except that the amount of hormone released from them is different
Detailed Description:
The study has previously been posted by Schering AG Germany Schering AG Germany has been renamed to Bayer Schering Pharma AG Germany
Bayer Schering Pharma AG Germany is the sponsor of the trial
Although the title of the study describes open it was in fact single-blinded
Issues on side effects are addressed in the Adverse Event section
Bayer Schering Pharma AG Germany is the sponsor of the trial
Although the title of the study describes open it was in fact single-blinded
Issues on side effects are addressed in the Adverse Event section
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 |
|---|---|---|---|
| 308901 | OTHER | Company internal | None |
| 2004-002291-42 | EUDRACT_NUMBER | None | None |