Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Estradiol · 1 trial · 1 indication
% Responders where a "Responder" is 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
Mean change from baseline to Day 15 in dyspareunia score (the self-identified most bothersome symptom in women with VVA). On a scale of 0 to 3, where 0 = none, 1=mild, 2=moderate and 3 = severe
| Arm | Type | Description |
|---|---|---|
| Estradiol vaginal inserts, 4 mcg | EXPERIMENTAL | Estradiol vaginal inserts, 4 mcg. Insert vaginally once daily for 14 days. |
| IMVEXXY® (estradiol vaginal inserts) 4 mcg | ACTIVE_COMPARATOR | IMVEXXY® (estradiol vaginal inserts) 4 mcg. Insert vaginally once for 14 days. |
| Placebo vaginal inserts | PLACEBO_COMPARATOR | Placebo vaginal inserts. Insert vaginally once for 14 days. |
| Name | Type | Description |
|---|---|---|
| Estradiol | DRUG | Vaginal Insert, 4 mcg tablet |
| Imvexxy | DRUG | Estradiol 4 mcg Vaginal Insert |
| Placebo | DRUG | Vehicle Vaginal Insert |
Inclusion Criteria: 1. Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations. 2. Females aged 40-75 years inclusive who are postmenopausal, with at least: 1. 12 months of spontaneous amenorrhea (women \<55 year of age with history of hysterectomy wit...
Estradiol is a small molecule being developed by Teva Pharmaceutical Industries Limited for the treatment of dyspareunia, which is pain during intercourse, in women with vulvar and vaginal atrophy. It is also studied in healthy volunteers for pharmacokinetic purposes. The drug is currently in Phase 3 clinical development.
Teva Pharmaceutical Industries Limited (NYSE: TEVA) is developing Estradiol. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating dyspareunia associated with vulvar and vaginal atrophy.
Estradiol is in Phase 3 clinical development. A completed Phase 3 trial (NCT05617820) compared Estradiol vaginal inserts 4 mcg to IMVEXXY (estradiol vaginal inserts 4 mcg) in the treatment of dyspareunia in women with vulvar and vaginal atrophy.
Estradiol has been studied in three clinical trials. Two Phase 1 trials (NCT01157182 and NCT01181726) evaluated Estradiol/Norethindrone Acetate Tablets under fasting and fed conditions in healthy women. A Phase 3 trial (NCT05617820) compared Estradiol vaginal inserts to IMVEXXY in treating dyspareunia.
Estradiol is an investigational drug still in clinical development. It has completed Phase 3 trials but has not been reported as FDA approved. The Phase 3 trial compared Estradiol vaginal inserts to IMVEXXY, which is an approved product, but Estradiol itself remains under investigation.
Estradiol is a form of estrogen, a female sex hormone. In the context of treating dyspareunia, it works by replacing estrogen in vaginal tissue, which helps restore the health of the vaginal lining and reduce pain during intercourse associated with vulvar and vaginal atrophy.