Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461305
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2007-04-17
Brief Title:
Safety Study of EthinylestradiolDrospirenone in Dysmenorrhea
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Multicenter Single-blind Randomized Study to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks 6 Cycles by Oral Administration of Drospirenone 3 mgEthinylestradiol 20 µg and Drospirenone 3 mg Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mgEthinylestradiol 20 µg Administered for 52 Weeks 13 Cycles
Status:
COMPLETED
Status Verified Date:
2013-01
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 efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
Detailed Description:
The drospirenone 3 mgethinylestradiol 20 μg 13 cycles group is to be treated by oral administration for 52 weeks 13 cycles The drospirenone 3 mgethinylestradiol 30 μg 6 cycles group is to be treated by oral administration for 24 weeks 6 cycles
The trial is sponsored by Bayer Yakuhin Ltd
The trial is sponsored by Bayer Yakuhin Ltd
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 |
|---|---|---|---|
| 310284 | OTHER | Company Internal | None |