ACTIVELLA

LOE Approaching

estradiol/norethindrone acetate

NDAORALTABLET

Approved

Nov 1998

Lifecycle

LOE Approaching

Competitive Pressure

30/100

Clinical Trials

Mechanism of Action

Estrogen Receptor Agonists

Pharmacologic Class:

Estrogen

Indications (4)

a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Prevention of Postmenopausal Osteoporosis Lopreeza 1 mg/0 a woman with a uterus for: Treatment of Moderate to Severe Symptoms of Vulvar Vaginal Atrophy due to Menopause 1 Osteoporosis

Clinical Trials (5)

NCT03271489Phase 3Completed

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Started Sep 2017

478 enrolled

Heavy Menstrual BleedingUterine Fibroids

NCT02691494Phase 3Completed

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

Started Feb 2016

378 enrolled

Uterine FibroidsHeavy Menstrual Bleeding

NCT02654054Phase 3Completed

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Started Dec 2015

413 enrolled

Uterine FibroidsHeavy Menstrual Bleeding

NCT01157182Phase 1Completed

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions

Started Feb 2007

36 enrolled

Healthy

NCT01181726Phase 1Completed

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions

Started Jan 2007

40 enrolled