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Transdermal 17Beta-estradiol, progesterone
This transdermal combination replaces estrogen and progesterone to restore hormonal balance in menopausal or postmenopausal women.
This transdermal combination replaces estrogen and progesterone to restore hormonal balance in menopausal or postmenopausal women. Used for Menopausal symptoms (hot flashes, night sweats, vaginal dryness), Osteoporosis prevention in postmenopausal women.
At a glance
| Generic name | Transdermal 17Beta-estradiol, progesterone |
|---|---|
| Also known as | Vivelle Dot transdermal patch, Prometrium |
| Sponsor | Massachusetts General Hospital |
| Drug class | Hormone replacement therapy (HRT) |
| Target | Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Women's Health / Endocrinology |
| Phase | Phase 3 |
Mechanism of action
17Beta-estradiol is the primary form of estrogen that binds to estrogen receptors (ERα and ERβ) throughout the body, while progesterone acts on progesterone receptors to provide endometrial protection and additional hormonal effects. Together, they mimic the natural hormonal cycle and alleviate menopausal symptoms while reducing certain long-term health risks associated with estrogen deficiency.
Approved indications
- Menopausal symptoms (hot flashes, night sweats, vaginal dryness)
- Osteoporosis prevention in postmenopausal women
Common side effects
- Breast tenderness
- Headache
- Nausea
- Vaginal bleeding or spotting
- Skin irritation at patch site
- Bloating
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)
- No More Sleepless Nights in Perimenopause (PHASE4)
- Effects of Estrogen on Heart Health in Women With Primary Ovarian Insufficiency
- Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (PHASE4)
- Estrogen Variability and Irritability During the Menopause Transition (PHASE4)
- Estrogen Supplementation and Bone Health in Women With CF (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 |
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