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Estradiol Tablets
At a glance
| Generic name | Estradiol Tablets |
|---|---|
| Also known as | Sublingual estradiol tablets, Oral Estradiol tablets, Oral 17(beta)-estradiol |
| Sponsor | Copenhagen University Hospital at Herlev |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Introvale, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Introvale is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 5.1 )
Common side effects
- Headache
- Nausea
- Abdominal pain
- Metrorrhagia
- Vaginal moniliasis
- Vaginal pain
- Acne
- Vaginitis
- Abdominal bloating
- Vomiting
- Edema
- Fluid retention
Serious adverse events
- Thromboembolic and thrombotic disorders
- Venous thrombosis with or without pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Carcinoma of the breast
- Carcinoma of the reproductive organs
- Hepatic neoplasia
- Gallbladder disease
- Budd-Chiari syndrome
Drug interactions
- Enzyme inducers (e.g., CYP3A4)
- Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort, and certain protease inhibitors
- Colesevelam
Key clinical trials
- Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment (PHASE2)
- Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
- Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors (PHASE1)
- Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) (PHASE2)
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (PHASE1)
- Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, 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:
- Estradiol Tablets CI brief — competitive landscape report
- Estradiol Tablets updates RSS · CI watch RSS
- Copenhagen University Hospital at Herlev portfolio CI