Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511797
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2007-08-03
Brief Title:
SH T00186 Phase II III Optimal Drospirenone DRSP Dose Finding and Placebo-controlled Comparative Study
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A Drospirenone 1 mgEthinylestradiol 20 µg as ß-cyclodextrin Clathrate SH T 04740E Drospirenone 2 mgEthinylestradiol 20 µg as ß-cyclodextrin Clathrate and SH T00186D Drospirenone 3 mg Ethinylestradiol 20 µg as ß-cyclodextrin Clathrate Administered Orally for 16 Weeks 4 Cycles and to Confirm the Efficacy of SH T00186D for Dysmenorrhea
Status:
COMPLETED
Status Verified Date:
2016-11
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 drospirenone for dysmenorrhea
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 310283 | OTHER | Company Internal | None |