Last reviewed · How we verify
Vagifem
At a glance
| Generic name | Vagifem |
|---|---|
| Also known as | vaginal estradiol, Vagifem (estradiol vaginal tablet) |
| Sponsor | University Hospitals Cleveland Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule
Common side effects
- Vulvovaginal Mycotic Infection
- Vulvovaginal Pruritus
- Back Pain
- Diarrhea
Serious adverse events
- Breast Cancer
- Endometrial Cancer
- Deep Vein Thrombosis
- Endometrial Hyperplasia
- Hypersensitivity
Key clinical trials
- Menopausal Hormones and Sympathetic Activation (PHASE4)
- Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients (PHASE3)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea (PHASE3)
- Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (PHASE1, PHASE2)
- A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PHASE1)
- 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)
- Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer (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 |