Tibolone
- Generic Name
- Tibolone
- 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
the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
- Conditions
- MenopauseSleep Disorder
- Interventions
- 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
Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
- First Posted Date
- 2022-10-06
- Last Posted Date
- 2024-05-30
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Registration Number
- NCT05568940
- Locations
- 🇨🇦
McGill University Health Center, Montreal, Quebec, Canada
HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
- Conditions
- Menopausal Syndrome
- Interventions
- First Posted Date
- 2022-03-15
- Last Posted Date
- 2024-06-17
- Lead Sponsor
- Far Eastern Memorial Hospital
- Target Recruit Count
- 100
- Registration Number
- NCT05280028
- Locations
- 🇨🇳
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan
The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
- Conditions
- Menopausal Syndromes
- Interventions
- 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
- Conditions
- Flow-mediated Dilation Evaluation of the Brachial Artery
- Interventions
- Drug: Placebo
- 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
- 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
- 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
- Conditions
- Perimenopausal Depression
- Interventions
- 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
Drug Development Updates
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