Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360529
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2006-08-03
Brief Title:
24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
Sponsor:
Sprout Pharmaceuticals Inc
Organization:
Sprout Pharmaceuticals Inc
Study Overview
Official Title:
A Twenty Four Week Randomized Double-Blind Placebo-Controlled Safety and Efficacy Trial of Flibanserin 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America
Status:
COMPLETED
Status Verified Date:
2016-06
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:
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder HSDD that meets standard diagnostic criteria Efficacy for flibanserin will be assessed vs a parallel placebo group
Detailed Description:
This trial was designed as a prospective multicenter trial containing a 24-week randomized double blind placebo controlled parallel-group period that assessed the effects of flibanserin maximum total daily dose 100 mg qd compared with placebo in premenopausal women with HSDD determined by Diagnostic and Statistical Manual IV- Text Revision DSM IV-TR criteria Three hundred patients were to be randomized to each treatment group This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks
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 |
|---|---|---|---|
| VIOLET | OTHER_GRANT | Boehringer Ingelheim | None |