Last reviewed · How we verify
Estradiol Transdermal
At a glance
| Generic name | Estradiol Transdermal |
|---|---|
| Also known as | Climara |
| Sponsor | University of Colorado, Denver |
| Drug class | Estrogen [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: ENDOMETRIAL CANCER WITH UNOPPOSED ESTROGEN IN WOMEN WITH A UTERUS There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen-only 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 out malignancy in menopausal women abnormal genital bleeding of unknown etiology [see Warnings and Precautions (5.2) ] . WARNING: ENDOMETRIAL CANCER WITH UNOPPOSED ESTROGEN IN WOMEN WITH A UTERUS See full prescribing information for complete boxed warning. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.2)
Common side effects
- Breast pain
- Upper respiratory tract infections
- Headaches
- Abdominal pain
- Pain
- Edema
- Application site reaction
- Nausea
- Nervousness
- Dizziness
- Anxiety
- Fatigue
Serious adverse events
- Breast cancer
- Cardiovascular Disorders
- Malignant Neoplasms
- Anaphylactic reactions
- Changes in blood pressure
- Palpitations
- Abdominal distension
- Contact lens intolerance
- Visual disturbances
- Pelvic pain
Key clinical trials
- Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea (PHASE3)
- Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
- Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency (PHASE3)
- Estradiol Supplementation and Rotator Cuff Repair (PHASE2)
- Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial (PHASE2)
- COMPASS - COpenhagen MenoPAuSe Study (PHASE2)
- Intrauterine Stent Placement Following Hysteroscopic Septum Resection (NA)
- Impact of Estradiol on Endothelial Function in Peri-Menopausal Women (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 Transdermal CI brief — competitive landscape report
- Estradiol Transdermal updates RSS · CI watch RSS
- University of Colorado, Denver portfolio CI