Approval Probability
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Estradiol Vaginal · 1 trial · 1 indication
A responder was defined as a subject with at least a 25% reduction from baseline in the sum of % basal/parabasal and % intermediate cells on vaginal cytology AND vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5, where baseline values were collected at Visit 1
| Arm | Type | Description |
|---|---|---|
| Estradiol Vaginal Insert 10 mcg | EXPERIMENTAL | Estradiol Vaginal Insert 10 mcg - Test Product |
| Vagifem Tablets 10 mcg | ACTIVE_COMPARATOR | Vagifem® (Estradiol Vaginal Tablets) 10 mcg - Reference Listed Drug |
| Placebo | PLACEBO_COMPARATOR | Placebo for the test product Estradiol Vaginal Tablets 10 mcg |
| Name | Type | Description |
|---|---|---|
| Estradiol Vaginal Tablets 10 mcg | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Willing and able to provide and understand written informed consent for the study. * Healthy female subject aged 30 to 75 years, inclusive, who was postmenopausal, defined as having had 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follic...
Estradiol Vaginal is used to treat atrophic vaginitis due to menopause. It is a small molecule estradiol product developed by Amneal Pharmaceuticals, Inc. (ticker AMRX) and is also known as Estradiol Vaginal Tablets 10 mcg. The condition involves vaginal atrophy linked to the menopausal decline in estrogen.
Estradiol Vaginal works as an agonist at ESR1, the estrogen receptor alpha. By binding and activating this receptor, it delivers estrogenic activity locally to vaginal tissue, which is the intended approach for treating atrophic vaginitis due to menopause. ESR1 agonism is the drug's established mechanism of action.
Estradiol Vaginal is developed by Amneal Pharmaceuticals, Inc., which trades under the ticker AMRX. Amneal is the company associated with this estradiol vaginal product candidate for atrophic vaginitis due to menopause.
Estradiol Vaginal is in Phase 3 development. It is an investigational product and is not approved. The Phase 3 program includes one completed trial, and no trials are currently active. The completed study enrolled 519 participants.
Estradiol Vaginal has been studied in the Phase 3 trial NCT01779947, titled a study to evaluate the safety and bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem 10 mcg and compare to placebo. The trial was completed, enrolled 519 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.