Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
estradiol · 6 trials · 2 indications
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.
| Arm | Type | Description |
|---|---|---|
| Vagifem® 10 mcg | EXPERIMENTAL | One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks |
| Trial part 1 | ACTIVE_COMPARATOR | - |
| Trial part 2 | EXPERIMENTAL | - |
| Low dose | EXPERIMENTAL | - |
| High dose | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| estradiol, 10 mcg | DRUG | Tablets, administered intravaginally twice weekly |
| estradiol, 25 mcg | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Postmenopausal women whose last menstruation was at least two years prior to the time of screening * At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual act...
Estradiol is a small molecule used to treat symptoms of menopause, specifically postmenopausal vaginal atrophy. It is being developed by Novo Nordisk A/S as a low-dose vaginal tablet. The drug is currently in Phase 3 clinical development for this indication.
Estradiol is a form of estrogen, a female sex hormone. It works by replacing the estrogen that decreases during menopause, which helps relieve symptoms such as vaginal atrophy. The drug is administered as a vaginal tablet to deliver the hormone locally.
Estradiol is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug for the treatment of postmenopausal vaginal atrophy.
Estradiol is in Phase 3 clinical development. It has completed six trials, including two Phase 3 studies, with a total enrollment of 1,105 participants. The drug is investigational and has not yet been approved by regulatory authorities.
Estradiol has been studied in several clinical trials, including NCT00108849 and NCT00431132, both Phase 3 studies for postmenopausal vaginal atrophy. Other trials include NCT01085877 and NCT01486979, which are Phase 1 studies. All trials have been completed.
Yes, estradiol is the active ingredient in Vagifem, a vaginal tablet used to treat postmenopausal vaginal atrophy. Clinical trials such as NCT00108849 and NCT00431132 specifically evaluated low doses of Vagifem in postmenopausal women.