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Norethisterone acetate
Norethisterone acetate is a Small molecule drug developed by Erasme University Hospital. It is currently FDA-approved. Also known as: Primolut.
Norethisterone acetate is a small molecule progestin medication used in birth control pills, menopausal hormone therapy, and for the treatment of various gynecological disorders such as heavy menstrual bleeding and fibroid uterus. It is available in low-dose and high-dose formulations and can be used alone or in combination with an estrogen.
At a glance
| Generic name | Norethisterone acetate |
|---|---|
| Also known as | Primolut |
| Sponsor | Erasme University Hospital |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- 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)
- Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
- Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL) (PHASE4)
- A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
- Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment (PHASE2)
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:
- Norethisterone acetate CI brief — competitive landscape report
- Norethisterone acetate updates RSS · CI watch RSS
- Erasme University Hospital portfolio CI
Frequently asked questions about Norethisterone acetate
What is Norethisterone acetate?
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Is Norethisterone acetate also known as anything else?
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Related
- Manufacturer: Erasme University Hospital — full pipeline
- Also known as: Primolut
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing