Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Estradiol Vaginal · 1 trial · 1 indication
Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks
| Arm | Type | Description |
|---|---|---|
| Estradiol 10 micrograms vaginal tablets | ACTIVE_COMPARATOR | One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments to maintain therapeutic response. |
| Promestriene 10mg./g vaginal cream | ACTIVE_COMPARATOR | One application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments to maintain therapeutic response. |
| Name | Type | Description |
|---|---|---|
| Estradiol 10 MCG Vaginal Tablet [VAGIFEM] | DRUG | To insert the tablets the patient must use the applicator provided in the way explained in the prospectus. |
| Promestriene Vaginal | DRUG | To insert the cream the patient must use the applicator provided in the way explained in the prospectus. |
Inclusion Criteria: * Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period * Women who have read and signed the Informed Consent Form * Women with an intact uterus * One or more vaginal symptoms (dryness, soreness,...
Estradiol vaginal is used to treat vulvovaginal atrophy, a condition in which the vaginal tissues thin and dry out. It is a low-dose estrogen therapy delivered directly to the vagina. Novo Nordisk A/S develops the product under the brand name Vagifem.
Estradiol vaginal works as an agonist at the estrogen receptor ESR1. By binding and activating this receptor in vaginal tissue, estradiol restores the local estrogen effect that is lost when circulating estrogen levels fall. This receptor activity underlies its use in vulvovaginal atrophy.
Estradiol vaginal is developed by Novo Nordisk A/S, which trades on the New York Stock Exchange under the ticker NVO. The company is the sponsor behind the estradiol 10 microgram vaginal tablet marketed as Vagifem.
Estradiol vaginal is in Phase 3 development. The program has one completed Phase 3 trial, and no trials are currently active. It is an investigational product in clinical development for vulvovaginal atrophy rather than a newly approved therapy.
Estradiol vaginal has been studied in the Phase 3 trial NCT04232813, titled Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream. That trial enrolled 120 female participants aged 45 years and older in Spain and is completed.
Yes. Estradiol vaginal is also known as estradiol 10 MCG vaginal tablet, marketed under the brand name Vagifem. Searches for Vagifem refer to the same low-dose estradiol vaginal tablet developed by Novo Nordisk A/S for vulvovaginal atrophy.