Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Estradiol
Estradiol/Norethindrone · 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/Norethindrone is being studied for the treatment of dyspareunia, which is painful sexual intercourse, in women with vulvar and vaginal atrophy. It is a small molecule combination therapy. The condition is associated with menopause and involves thinning and inflammation of vaginal tissues.
Estradiol/Norethindrone targets the estrogen receptor 1 (ESR1) as an agonist. By activating ESR1, the estradiol component helps restore vaginal tissue, while norethindrone provides progestational activity. This mechanism is intended to alleviate symptoms of vulvar and vaginal atrophy, including dyspareunia.
Estradiol/Norethindrone is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is a global pharmaceutical company headquartered in Israel.
Estradiol/Norethindrone is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for any indication. The Phase 3 trial has been completed.
Estradiol/Norethindrone has been evaluated in a Phase 3 clinical trial, NCT05617820, titled "Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY (Estradiol Vaginal Inserts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvar and Vaginal Atrophy." The trial enrolled 1,050 participants and was completed.
Estradiol/Norethindrone is also known as Estradiol/Norethindrone acetate or simply Estradiol. These names refer to the same combination product. The drug combines estradiol with norethindrone acetate.