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
-

the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

First Posted Date
2023-11-07
Last Posted Date
2024-01-02
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
180
Registration Number
NCT06117969

The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill

First Posted Date
2023-05-06
Last Posted Date
2023-08-24
Lead Sponsor
Guoqing Zhou
Target Recruit Count
276
Registration Number
NCT05846698
Locations
🇨🇳

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China

The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder

First Posted Date
2013-04-02
Last Posted Date
2022-02-23
Lead Sponsor
Far Eastern Memorial Hospital
Target Recruit Count
125
Registration Number
NCT01822288
Locations
🇨🇳

Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

First Posted Date
2012-09-06
Last Posted Date
2015-04-03
Lead Sponsor
Federal University of Minas Gerais
Target Recruit Count
60
Registration Number
NCT01679795
Locations
🇧🇷

hospital das Clinicas - Universidade Federal de Minas Gerais, belo Horizonte, minas Gerais, Brazil

Vascular Effect of Tibolone in the Brachial Artery

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2012-03-05
Last Posted Date
2015-04-03
Lead Sponsor
Selmo Geber
Target Recruit Count
60
Registration Number
NCT01543399
Locations
🇧🇷

hospital das Clinicas - Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

Tibolone and Placebo in Adjunct to Antidepressant Medication for Women With Menopausal Depression

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-11-11
Last Posted Date
2020-01-09
Lead Sponsor
The Alfred
Target Recruit Count
120
Registration Number
NCT01470092
Locations
🇦🇺

The Alfred Hospital, Melbourne, Victoria, Australia

Investigation of Tibolone and Escitalopram in Perimenopausal Depression

First Posted Date
2011-06-07
Last Posted Date
2015-03-31
Lead Sponsor
The Alfred
Target Recruit Count
2
Registration Number
NCT01368068
Locations
🇦🇺

The Alfred Hospital, Melbourne, Victoria, Australia

High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone

First Posted Date
2008-12-16
Last Posted Date
2010-02-02
Lead Sponsor
Keogh Institute for Medical Research
Target Recruit Count
20
Registration Number
NCT00809068
Locations
🇦🇺

Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands, Perth, Western Australia, Australia

Tibolone Endometrium Study (Study 32972)(P06470)

First Posted Date
2008-09-03
Last Posted Date
2022-02-03
Lead Sponsor
Organon and Co
Target Recruit Count
32
Registration Number
NCT00745108

A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-07-30
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
102
Registration Number
NCT00725374
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