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Also known as Estradiol Vaginal Cream, 0.01%
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 to treat atrophic vaginitis, a condition of vaginal dryness and thinning in postmenopausal women. It is a small molecule estrogen therapy applied vaginally. The Phase 3 program enrolled postmenopausal females aged 40 years and older with atrophic vaginitis.
Estradiol Vaginal, 0.01% targets ESR1, the estrogen receptor alpha, and acts as an agonist. Binding to ESR1 activates estrogen receptor signaling in vaginal tissue. This is the mechanism underlying its use in atrophic vaginitis, where estrogen deficiency causes vaginal atrophy.
Estradiol Vaginal, 0.01% is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical development program for this estradiol vaginal cream product.
Estradiol Vaginal, 0.01% is in Phase 3 development. It is an investigational product and is not approved. The Phase 3 trial has been completed, and no active trials are currently listed for this asset.
Estradiol Vaginal, 0.01% was studied in the completed Phase 3 trial NCT02195986, titled A Comparison of Estradiol Vaginal Cream to Estrace Cream in 350 Postmenopausal Females With Atrophic Vaginitis. The trial enrolled 366 participants in the United States, was randomized, double blind, and placebo controlled.
Yes. Estradiol Vaginal, 0.01% is also known as Estradiol Vaginal Cream, 0.01%. Both names refer to the same investigational estradiol vaginal cream product developed by Viatris Inc. for atrophic vaginitis.