Drugs / Tibolone
Tibolone
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00165204 | Apr 2004 → Mar 2006 | breast cancer, postmenopausal osteoporosis, premature menopause | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT00299364 | Sep 2004 → May 2005 | — | Schaper & Bruemmer GmbH & Co KG | Completed | No outcome recorded |
| Phase 3 | NCT00413764 | Mar 2004 → Nov 2005 | sexual disorder | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00745108 | Oct 2001 → Jul 2005 | — | Organon and Co | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06117969 | Dec 2023 → Jun 2024 | sleep disorder | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01822288 | Nov 2012 → Jul 2021 | — | Far Eastern Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01368068 | Jul 2012 | — | The Alfred | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00294463 | Feb 2003 → Mar 2005 | osteoporosis | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00431431 | Jul 2000 → Feb 2005 | — | Organon and Co | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01543399 | Mar 2012 → Feb 2015 | — | Selmo Geber | Completed | No outcome recorded |
| — | NCT01679795 | Feb 2012 → Feb 2015 | — | Federal University of Minas Gerais | Completed | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT01239888 Comparator | Jan → Nov 2012 | major depressive disorder | The Alfred | Unknown | No outcome recorded |
| Phase 3 | NCT00725374 Comparator | Dec 2002 → Apr 2005 | breast cancer | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00408863 Comparator | May 2002 → Oct 2007 | breast cancer | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00519857 Comparator | Jul 2001 → Aug 2006 | osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT02393482 Comparator | Jun → Dec 2021 | amenorrhea, endometriosis | University of Cagliari | Unknown | No outcome recorded |
| Phase 4 | NCT01470092 Comparator | Jul 2012 → Dec 2017 | — | The Alfred | Completed | No outcome recorded |
| Phase 4 | NCT00472004 Comparator | Feb 2006 → Dec 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00145522 Comparator | Nov 2005 → Mar 2009 | — | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00809068 Comparator | Aug 2005 → Aug 2009 | — | Keogh Institute for Medical Research | Completed | No outcome recorded |
| Phase 4 | NCT00431093 Comparator | Nov 2002 → Mar 2005 | — | Organon and Co | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-10-13 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory GenSci Advances Women's Health with the Approval of Two Key Products genscigroup.com ↗
Recently, the National Medical Products Administration (NMPA) of China announced that Gensci’s Corifollitropin alfa N02 for injection (Jin Saijia) and Tibolone tablets (Jin Saibei), both dedicated to women's health, have received approval. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-10-13 | Changchun GeneScience Pharmaceutical Co., Ltd. | GenSci Advances Women's Health with the Approval of Two Key Products genscigroup.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tibolone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00809068 ↗ |
| Known as | Livial | “Tibolone-group (2.5 mg tibolone (Livial, N.V. Organon, Oss, The Netherlands) administered orally every day, starting 21 days prior to surgery)” NCT00294463 ↗ |
| Known as | Livial (tibolone) | “Livial (tibolone)” NCT01239888 ↗ |
| Known as | Org OD-14 | “2 years treatment with tibolone (1.25 mg Org OD-14)” NCT00431431 ↗ |
| Action | Activate | “The mechanism of tibolone on HDL cholesterol has been suggested to result from an acceleration of the catabolism of HDL by stimulation of hepatic lipase with no effect on...” NCT00809068 ↗ |
| Modality | Other / unclassified | “Tibolone, a synthetic steroid, is effective in reducing these symptoms in healthy post-menopausal women” PMID 22030384 ↗ Oct 2011 |
| Route | Oral | “2.5 mg tibolone (Livial, N.V. Organon, Oss, The Netherlands) administered orally every day” NCT00294463 ↗ |