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Hormone replacement therapy
Hormone replacement therapy supplements deficient endogenous hormones (typically estrogen and/or progesterone) to alleviate symptoms of hormonal imbalance or deficiency.
Hormone replacement therapy supplements deficient endogenous hormones (typically estrogen and/or progesterone) to alleviate symptoms of hormonal imbalance or deficiency. Used for Menopausal vasomotor symptoms (hot flashes, night sweats), Genitourinary atrophy and sexual dysfunction, Osteoporosis prevention in postmenopausal women.
At a glance
| Generic name | Hormone replacement therapy |
|---|---|
| Also known as | Estradiol, Prometrium, Micronized progestin, Medroxyprogesterone, Climera |
| Sponsor | Faculdade de Medicina do ABC |
| Drug class | Hormone replacement therapy |
| Target | Estrogen receptor (ER-α, ER-β), Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Women's Health |
| Phase | FDA-approved |
Mechanism of action
HRT works by restoring circulating levels of hormones that decline naturally with age or due to surgical/medical intervention. In menopausal women, exogenous estrogen and progestin bind to estrogen and progesterone receptors throughout the body, reducing vasomotor symptoms, improving bone density, and addressing genitourinary and mood-related symptoms. The specific formulation and route of administration determine tissue distribution and systemic exposure.
Approved indications
- Menopausal vasomotor symptoms (hot flashes, night sweats)
- Genitourinary atrophy and sexual dysfunction
- Osteoporosis prevention in postmenopausal women
- Mood and cognitive symptoms associated with menopause
Common side effects
- Breast tenderness
- Vaginal bleeding or spotting
- Headache
- Nausea
- Venous thromboembolism (VTE)
- Breast cancer (long-term use)
- Stroke
Key clinical trials
- Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy (PHASE2)
- HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients (PHASE3)
- Efficacy METAZYM for the Treatment Metachromatic Leukodystrophy Treated With Hematopoietic Stem Cell Transplantation (PHASE2)
- Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
- Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy (NA)
- Gene Replacement Therapy for Treatment of Paediatric Patients With CTNNB1 Neurodevelopmental Syndrome (PHASE1, PHASE2)
- Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial (NA)
- Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) (NA)
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:
- Hormone replacement therapy CI brief — competitive landscape report
- Hormone replacement therapy updates RSS · CI watch RSS
- Faculdade de Medicina do ABC portfolio CI