Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EVO100 · 2 trials · 4 indications
Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
| Arm | Type | Description |
|---|---|---|
| EVO100 gel | EXPERIMENTAL | EVO100 vaginal gel, 5 g |
| Placebo gel | PLACEBO_COMPARATOR | Placebo vaginal gel, 5 g |
| EVO100 | ACTIVE_COMPARATOR | A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse. |
| Placebo | PLACEBO_COMPARATOR | An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse. |
| Name | Type | Description |
|---|---|---|
| EVO100 | DRUG | EVO100 vaginal gel |
| Placebo | DRUG | Placebo vaginal gel |
Subject Recruitment: EVOGUARDStudy.com/ct Inclusion Criteria: * Subjects must meet both of the following criteria: 1. Urogenital CT and/or GC infection (documented in a retrievable medical record) within the 16 weeks prior to enrollment and one or more of the additional risk factors included be...