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Add back therapy 1 (tibolone)
Tibolone is a synthetic steroid that acts as a selective tissue estrogenic activity regulator (STEAR), providing estrogenic, progestagenic, and androgenic effects to alleviate menopausal symptoms.
Tibolone is a synthetic steroid that acts as a selective tissue estrogenic activity regulator (STEAR), providing estrogenic, progestagenic, and androgenic effects to alleviate menopausal symptoms. Used for Menopausal vasomotor symptoms (hot flushes, night sweats), Postmenopausal bone loss prevention, Postmenopausal vaginal atrophy.
At a glance
| Generic name | Add back therapy 1 (tibolone) |
|---|---|
| Sponsor | University of Cagliari |
| Drug class | Selective Tissue Estrogenic Activity Regulator (STEAR); Hormone Replacement Therapy |
| Target | Estrogen receptor, Progesterone receptor, Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology; Women's Health |
| Phase | FDA-approved |
Mechanism of action
Tibolone is a prodrug that is metabolized in the body to three active metabolites with different tissue-selective activities. It binds to estrogen, progesterone, and androgen receptors with varying affinities depending on the tissue, providing symptom relief in menopause while minimizing some adverse effects associated with conventional hormone replacement therapy. This selective activity profile makes it particularly useful for managing vasomotor symptoms and bone loss in postmenopausal women.
Approved indications
- Menopausal vasomotor symptoms (hot flushes, night sweats)
- Postmenopausal bone loss prevention
- Postmenopausal vaginal atrophy
Common side effects
- Vaginal bleeding or spotting
- Breast tenderness
- Headache
- Nausea
- Weight gain
Key clinical trials
- Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
- Psychological Impact of Amenorrhea in Women With Endometriosis (PHASE4)
- Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis (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:
- Add back therapy 1 (tibolone) CI brief — competitive landscape report
- Add back therapy 1 (tibolone) updates RSS · CI watch RSS
- University of Cagliari portfolio CI