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estradiol-norethisterone
Estradiol-norethisterone is a combination of an estrogen and a progestin that works by replacing natural hormones in the body.
Estradiol-norethisterone is a combination of an estrogen and a progestin that works by replacing natural hormones in the body. Used for Treatment of moderate to severe vasomotor symptoms associated with menopause, Prevention of postmenopausal osteoporosis.
At a glance
| Generic name | estradiol-norethisterone |
|---|---|
| Also known as | Combipatch®, Estalis® |
| Sponsor | Organon and Co |
| Drug class | estrogen/progestin combination |
| Modality | Small molecule |
| Therapeutic area | Women's Health |
| Phase | Phase 3 |
Mechanism of action
Estradiol is an estrogen that helps to replace estrogen in the body, while norethisterone is a progestin that helps to regulate the menstrual cycle and prevent uterine cancer. This combination of hormones helps to alleviate symptoms of menopause and prevent osteoporosis.
Approved indications
- Treatment of moderate to severe vasomotor symptoms associated with menopause
- Prevention of postmenopausal osteoporosis
Common side effects
- Breast tenderness
- Headache
- Nausea
- Vaginal bleeding
- Abdominal cramps
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-norethisterone CI brief — competitive landscape report
- estradiol-norethisterone updates RSS · CI watch RSS
- Organon and Co portfolio CI