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Estradiol/norethindrone acetate
Estradiol and norethindrone acetate work together as a hormone replacement therapy, with estradiol providing estrogen and norethindrone acetate providing progestin to supplement declining hormones.
Estradiol and norethindrone acetate work together as a hormone replacement therapy, with estradiol providing estrogen and norethindrone acetate providing progestin to supplement declining hormones. Used for Moderate to severe vasomotor symptoms associated with menopause, Moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.
At a glance
| Generic name | Estradiol/norethindrone acetate |
|---|---|
| Also known as | E2/NETA, low-dose hormonal add-back, E2/NETA placebo, Activella, Mimvey® |
| Sponsor | Myovant Sciences GmbH |
| Drug class | Hormone replacement therapy (HRT) |
| Target | Estrogen receptor alpha and beta; progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Women's Health / Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Estradiol is a bioidentical estrogen that binds to estrogen receptors to alleviate vasomotor symptoms and other menopausal symptoms. Norethindrone acetate is a synthetic progestin that protects the endometrium from unopposed estrogen stimulation, reducing the risk of endometrial hyperplasia and cancer. Together, they restore hormonal balance in postmenopausal women.
Approved indications
- Moderate to severe vasomotor symptoms associated with menopause
- Moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause
Common side effects
- Breast tenderness
- Headache
- Nausea
- Vaginal bleeding/spotting
- Abdominal pain
Key clinical trials
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)
- Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age (EARLY_PHASE1)
- Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain (PHASE3)
- Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (PHASE3)
- Ovulation Incidence in Oral Contraceptive Users (PHASE3)
- Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive (PHASE1)
- Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Estradiol/norethindrone acetate CI brief — competitive landscape report
- Estradiol/norethindrone acetate updates RSS · CI watch RSS
- Myovant Sciences GmbH portfolio CI