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estradiol plus progesterone
estradiol plus progesterone is a Hormone replacement therapy (HRT) Small molecule drug developed by Peking Union Medical College Hospital. It is currently FDA-approved for Menopausal vasomotor symptoms (hot flashes, night sweats), Postmenopausal osteoporosis prevention, Genitourinary atrophy and related symptoms.
Estradiol and progesterone together provide hormone replacement therapy by restoring circulating levels of endogenous female sex hormones.
Estradiol and progesterone together provide hormone replacement therapy by restoring circulating levels of endogenous female sex hormones. Used for Menopausal vasomotor symptoms (hot flashes, night sweats), Postmenopausal osteoporosis prevention, Genitourinary atrophy and related symptoms.
At a glance
| Generic name | estradiol plus progesterone |
|---|---|
| Sponsor | Peking Union Medical College Hospital |
| Drug class | Hormone replacement therapy (HRT) |
| Target | Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Women's Health |
| Phase | FDA-approved |
Mechanism of action
Estradiol is a potent estrogen that binds to estrogen receptors (ERα and ERβ) throughout the body, while progesterone binds to progesterone receptors. Together, they restore hormonal balance in postmenopausal or hypogonadal women, alleviating vasomotor symptoms and supporting bone health, cardiovascular function, and genitourinary health. The combination is designed to mimic the natural hormonal cycle more closely than estrogen monotherapy.
Approved indications
- Menopausal vasomotor symptoms (hot flashes, night sweats)
- Postmenopausal osteoporosis prevention
- Genitourinary atrophy and related symptoms
Common side effects
- Breast tenderness
- Vaginal bleeding or spotting
- Headache
- Nausea
- Bloating
- Increased risk of venous thromboembolism
- Increased risk of breast cancer (with long-term use)
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)
- Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients (NA)
- Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study
- A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) (PHASE2)
- Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer
- A Prospective Multicenter Observational Real-world Study of Retained Products of Conception
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 plus progesterone CI brief — competitive landscape report
- estradiol plus progesterone updates RSS · CI watch RSS
- Peking Union Medical College Hospital portfolio CI
Frequently asked questions about estradiol plus progesterone
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Related
- Drug class: All Hormone replacement therapy (HRT) drugs
- Target: All drugs targeting Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR)
- Manufacturer: Peking Union Medical College Hospital — full pipeline
- Therapeutic area: All drugs in Endocrinology / Women's Health
- Indication: Drugs for Menopausal vasomotor symptoms (hot flashes, night sweats)
- Indication: Drugs for Postmenopausal osteoporosis prevention
- Indication: Drugs for Genitourinary atrophy and related symptoms
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing