Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Lopreeza is indicated for: Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2) Limitations of Use : When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to… FDA label
estradiol · 9 trials · 4 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 |
| ALD 0.1 | EXPERIMENTAL | - |
| ALD 0.25 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Trial part 1 | ACTIVE_COMPARATOR | - |
| Trial part 2 | EXPERIMENTAL | - |
| New formulation | EXPERIMENTAL | - |
| Old formulation | ACTIVE_COMPARATOR | - |
| Low dose | EXPERIMENTAL | - |
| High dose | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| estradiol, 10 mcg | DRUG | Tablets, administered intravaginally twice weekly |
| 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) | DRUG | One tablet per day for 24 weeks |
| 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) | DRUG | One tablet per day for 24 weeks |
| placebo | DRUG | Placebo tablets for 24 weeks |
| estradiol, 25 mcg | DRUG | - |
| 2 mg estradiol / 1 mg norethisterone acetate (NETA) | DRUG | A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally. |
| 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) | DRUG | A single oral dose of 1 tablet under fasting conditions |
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 used for hormone replacement therapy in menopause. It is being developed by Novo Nordisk A/S as a treatment for menopausal symptoms, including postmenopausal vaginal atrophy. The program includes oral and vaginal formulations studied in postmenopausal women.
Estradiol targets ESR1, the estrogen receptor alpha, and acts as an agonist at this receptor. By activating ESR1, estradiol mimics endogenous estrogen signaling, which underlies its use in hormone replacement therapy for menopause.
Estradiol is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company has run a clinical program of nine completed trials evaluating estradiol formulations, including combinations with norethisterone acetate, in menopausal and postmenopausal women.
Estradiol is in Phase 3 development for menopause. It is an investigational small molecule and is not described as approved. The program includes nine completed trials with a total enrollment of 1,749 participants, and no trials are currently active.
Completed estradiol trials include NCT01596010, which compared two oral estradiol and norethisterone formulations in healthy women; NCT01486979, a pharmacokinetic study in postmenopausal women with atrophic vaginitis; NCT01477632, a bioavailability study of three oral hormone replacement formulations; and NCT01085877, comparing two vaginal tablets in postmenopausal women with atrophic vaginitis.