Ignite Creation Date:
2024-05-06 @ 7:16 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02503306
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2015-07-17
Brief Title:
Efficacy and Tolerability Study of Avanafil in Russia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Clinical Trial on Efficacy and Tolerability of Two Different Single Doses of Avanafil in Russia
Status:
COMPLETED
Status Verified Date:
2016-03
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:
CEDAR
Brief Summary:
Primary Objective
o To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period
The change in percent of sexual attempts in which subjects are able to insert the penis into the partners vagina
The change in score on the erectile function EF domain of the International Index of Erectile Function IIEF questionnaire
Secondary Objective
o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction ED
o To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period
The change in percent of sexual attempts in which subjects are able to insert the penis into the partners vagina
The change in score on the erectile function EF domain of the International Index of Erectile Function IIEF questionnaire
Secondary Objective
o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction ED
Detailed Description:
The total study duration per patient will be up to 12 weeks consisting of an 8-week treatment period and a 4-week run-in period
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 |
|---|---|---|---|
| U1111-1167-6889 | OTHER | UTN | None |