Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05617820 | Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy | PHASE3 | COMPLETED | 1,050 | — | — | Nov 15, 2022 | Mar 15, 2024 | Apr 12, 2024 | 48 | United States, El Salvador +1 |
% Responders where a "Responder" is defined as a patient with: At least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology; and Vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5
Mean change from baseline to Day 15 in dyspareunia score (the self-identified most bothersome symptom in women with VVA). On a scale of 0 to 3, where 0 = none, 1=mild, 2=moderate and 3 = severe
| Arm | Type | Description |
|---|---|---|
| Estradiol vaginal inserts, 4 mcg | EXPERIMENTAL | Estradiol vaginal inserts, 4 mcg. Insert vaginally once daily for 14 days. |
| IMVEXXY® (estradiol vaginal inserts) 4 mcg | ACTIVE_COMPARATOR | IMVEXXY® (estradiol vaginal inserts) 4 mcg. Insert vaginally once for 14 days. |
| Placebo vaginal inserts | PLACEBO_COMPARATOR | Placebo vaginal inserts. Insert vaginally once for 14 days. |
| Name | Type | Description |
|---|---|---|
| Estradiol | DRUG | Vaginal Insert, 4 mcg tablet |
| Imvexxy | DRUG | Estradiol 4 mcg Vaginal Insert |
| Placebo | DRUG | Vehicle Vaginal Insert |
Inclusion Criteria: 1. Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations. 2. Females aged 40-75 years inclusive who are postmenopausal, with at least: 1. 12 months of spontaneous amenorrhea (women \<55 year of age with history of hysterectomy wit...