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Adjusted LOA
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AVANAFIL · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Avanafil dose 1 | EXPERIMENTAL | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Avanafil dose 2 | EXPERIMENTAL | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Placebo | PLACEBO_COMPARATOR | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Name | Type | Description |
|---|---|---|
| AVANAFIL | DRUG | Pharmaceutical form:tablets Route of administration: oral |
| placebo | DRUG | Pharmaceutical form:tablets Route of administration: oral |
Inclusion criteria: * Male subjects, age ≥18 years. * Minimum 6-month history of mild to severe erectile dysfunction prior to the enrollment into the study. * Subject is in a monogamous, heterosexual relationship for at least 3 months prior to the enrollment into the study. * Subject agrees to make...
Avanafil is used for erectile dysfunction, a sexual function and fertility disorder. It is being developed as a small molecule treatment for this condition. The drug is currently in Phase 3 clinical development and is not yet approved for use.
Avanafil is being developed by Sanofi, a company traded under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug's efficacy and tolerability for the treatment of erectile dysfunction.
Avanafil is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its safety and effectiveness in treating erectile dysfunction.
Avanafil has one completed Phase 3 clinical trial, identified as NCT02503306. This study, titled 'Efficacy and Tolerability Study of Avanafil in Russia,' enrolled 189 male participants aged 18 years and older. The trial was randomized, double-blind, and placebo-controlled.
Avanafil is a distinct drug entity. It is not known to be the same as any other marketed medication. Its unique chemical structure and mechanism of action differentiate it from other treatments for erectile dysfunction.