Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Estradiol Vaginal, 0.01% · 1 trial · 1 indication
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8. A responder was 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.
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8. A responder was 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.
| Arm | Type | Description |
|---|---|---|
| Estradiol Vaginal Cream | EXPERIMENTAL | Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. |
| Estrace® 0.01% cream | ACTIVE_COMPARATOR | Estrace® 0.01% vaginal cream, administered once daily for 7 days. |
| Placebo Vaginal Cream | PLACEBO_COMPARATOR | Placebo Vaginal Cream, administered once daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| Estradiol Vaginal Cream, 0.01% | DRUG | Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days) |
| Estrace® 0.01% cream | DRUG | Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days) |
| Placebo Vaginal Cream | DRUG | Placebo Vaginal Cream ( 1 x 2 g for 7 days) |
Inclusion Criteria: 1. Capable of providing informed consent. 2. Age: 40-70 years old. 3. Sex: Female 4. Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ml or at least 6 weeks postsurgical bilatera...
Estradiol Vaginal, 0.01% is used for atrophic vaginitis, a condition in postmenopausal females. It is a small molecule endocrine therapy being developed by Viatris Inc. The drug is currently in Phase 3 clinical development and is investigational, not yet approved.
Estradiol Vaginal, 0.01% is a small molecule that delivers estradiol, a form of estrogen, locally to the vaginal tissue. It is designed to address atrophic vaginitis by supplementing estrogen levels in the vaginal area, which decline after menopause.
Estradiol Vaginal, 0.01% is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The drug is in Phase 3 clinical trials for atrophic vaginitis.
Estradiol Vaginal, 0.01% is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not yet available on the market.
Estradiol Vaginal, 0.01% has one completed Phase 3 trial, NCT02195986, which compared it to Estrace Cream in 366 postmenopausal females with atrophic vaginitis. The trial was randomized, double-blind, and placebo-controlled, conducted in the United States with healthy volunteers.