Tibolone

Generic Name
Tibolone
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C21H28O2
CAS Number
5630-53-5
Unique Ingredient Identifier
FF9X0205V2
Background

Tibolone is a synthetic steroid hormone drug, which is mainly non-selective in its binding profile, acting as an agonist primarily at estrogen receptors (ER), with a preference for ER alpha .

Tibolone (Livial, Org OD 14), produced by Organon (West Orange, NJ), is a synthetic steroid that possesses estrogenic, androgenic and progestogenic properties. It has been used in Europe for almost 2 decades, primarily for the prevention of postmenopausal osteoporosis and the treatment of post-menopausal symptoms . Tibolone is approved in 90 countries to manage menopausal symptoms and in 45 countries to prevent the development of osteoporosis .

In June 2006, Organon Pharmaceuticals announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for tibolone had not been approved .

Interestingly, the use of tibolone in the treatment cardiovascular disease has been studied with inconclusive results . Tibolone has been to have anti-resorptive effects on bone .

Indication

For the relief of post-menopausal symptoms and for the prevention of osteoporosis .

Associated Conditions
Vasomotor Symptoms Associated With Menopause
Associated Therapies
-

Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-08-23
Last Posted Date
2022-02-03
Lead Sponsor
Organon and Co
Target Recruit Count
4534
Registration Number
NCT00519857

Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)

First Posted Date
2007-02-05
Last Posted Date
2022-02-03
Lead Sponsor
Organon and Co
Target Recruit Count
570
Registration Number
NCT00431093

Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-02-05
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
324
Registration Number
NCT00431431

Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)

First Posted Date
2006-12-20
Last Posted Date
2022-02-04
Lead Sponsor
Organon and Co
Target Recruit Count
358
Registration Number
NCT00413764

Livial Intervention Following Breast Cancer; Efficacy, Recurrence and Tolerability Endpoints (LIBERATE)(COMPLETED)(P05885)

First Posted Date
2006-12-07
Last Posted Date
2022-02-04
Lead Sponsor
Organon and Co
Target Recruit Count
3148
Registration Number
NCT00408863

Effects of Tibolone Treatment on the Endometrium

Phase 4
Completed
Conditions
First Posted Date
2006-02-22
Last Posted Date
2006-02-22
Lead Sponsor
Erasmus Medical Center
Target Recruit Count
35
Registration Number
NCT00294463
Locations
🇳🇱

Erasmus MC, Rotterdam, Netherlands

Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy

First Posted Date
2005-09-14
Last Posted Date
2007-12-21
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
50
Registration Number
NCT00165204
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

Phase 4
Completed
Conditions
Interventions
First Posted Date
2005-09-05
Last Posted Date
2009-04-01
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
135
Registration Number
NCT00145522
Locations
🇮🇹

Site 8, Ancona, Italy

🇮🇹

Site 9, Firenze, Italy

🇮🇹

Sit 14, Modena, Italy

and more 8 locations
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