Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-26 @ 12:10 PM
Study NCT ID:
NCT02503306
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability Study of Avanafil in Russia
Sponsor:
Sanofi
Organization:
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 partner's 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 partner's 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1167-6889 | OTHER | UTN | View |