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
Also known as Activella
estradiol/ norethindrone · 2 trials · 3 indications
Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over 35 days prior to each visit. Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic).
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics).
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. |
| Elagolix / Elagolix + E2/NETA | EXPERIMENTAL | Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. |
| Elagolix + E2/NETA | EXPERIMENTAL | Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. |
| Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA) | EXPERIMENTAL | Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) |
| Elagolix | EXPERIMENTAL | Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD |
| Name | Type | Description |
|---|---|---|
| Estradiol/Norethindrone Acetate | DRUG | Tablets |
| Placebo for Elagolix | DRUG | Tablet |
| Elagolix | DRUG | Tablet |
| Placebo for E2/NETA | DRUG | Tablets |
Inclusion Criteria: * Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening. * Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Sc...
Estradiol/norethindrone is a combination hormone therapy being developed for endometriosis and uterine fibroids. It pairs estradiol, an estrogen, with norethindrone acetate, a progestin, to address conditions driven by hormonal activity in premenopausal women. It is an investigational small molecule product and is not described as approved.
Estradiol/norethindrone targets ESR1, the estrogen receptor alpha. Estradiol acts as an agonist at this receptor, while norethindrone acetate contributes progestin activity. Together they modulate estrogen-driven signaling relevant to endometriosis and uterine fibroids.
Estradiol/norethindrone is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical development program for this combination therapy.
Estradiol/norethindrone is in Phase 3 development. It is an investigational therapy and is not described as FDA approved. The program includes completed Phase 3 trials in endometriosis and in uterine fibroids with heavy menstrual bleeding.
The program includes NCT03213457, a completed Phase 3 trial in moderate to severe endometriosis-associated pain with 681 participants, and NCT02925494, a completed Phase 3 extension study in premenopausal women with heavy menstrual bleeding associated with uterine fibroids with 433 participants. Both were randomized, double-blind, and placebo-controlled.