Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for the treatment of atrophic vaginitis due to menopause. It is a small molecule being developed by Amneal Pharmaceuticals, Inc. for this endocrine condition. The drug is currently in Phase 3 clinical development.
Estradiol Vaginal contains estradiol, a form of estrogen. It works by replacing estrogen locally in the vaginal tissue to relieve symptoms of atrophic vaginitis, which occurs when estrogen levels decline after menopause.
Estradiol Vaginal is being developed by Amneal Pharmaceuticals, Inc., a company traded on the New York Stock Exchange under the ticker symbol AMRX. The drug is currently in Phase 3 clinical development for atrophic vaginitis due to menopause.
Estradiol Vaginal is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 3 trial has been completed, and the drug is being studied for atrophic vaginitis due to menopause.
Estradiol Vaginal has one completed Phase 3 trial, NCT01779947, which evaluated the safety and bioequivalence of estradiol vaginal inserts, 10 mcg, compared to Vagifem 10 mcg and placebo. The trial enrolled 519 women aged 30 years and older in the United States.
Estradiol Vaginal is being studied as a potential generic equivalent to Vagifem. A Phase 3 trial compared estradiol vaginal inserts, 10 mcg, to Vagifem 10 mcg and placebo to evaluate safety and bioequivalence. The drug is not yet approved.