18 completed, 4 unknown, 1 recruiting, 1 terminated. 12 Phase 4, 6 Phase 3, 2 Not applicable, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 12 | Completed 8, Unknown 3, Terminated 1 |
| Phase 3 | 6 | Completed 6 |
| Not applicable | 2 | Completed 2 |
| Phase 1 | 1 | Unknown 1 |
| Phase 2 | 1 | Completed 1 |
Follow tibolone: new trials by email Literature Review of tibolone trials Research Report on tibolone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids Tibolone 2.5 Mg Oral Tablet - Endometriosis, Fibroids | Withdrawn | McGill University Health Centre/Research Institute of the McGill University Health Centre | 2024-09-01 | 2024-05-30 | ||
| the Effects of Different Therapy Regimens on Menopausal Sleep Disorders Tibolone, Xiangshao granules, Tibolone plus Xiangshao granules - Menopause, Sleep Disorder | Phase 4 | Unknown | Peking Union Medical College Hospital | 180 | 2023-12-30 | 2024-01-02 |
| HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness Tibolone 2.5 mg, Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg - Menopausal Syndrome | Recruiting | Far Eastern Memorial Hospital | 100 | 2022-02-07 | 2024-06-17 | |
| The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill Luo-Bu-Fu-Ke-Bi-RI Pill, tibolone - Climacteric Syndrome | Completed | Guoqing Zhou | 300 | 2021-09-05 | 2026-09-09 | |
| Psychological Impact of Amenorrhea in Women With Endometriosis Estroprogestinic therapy (Etinil-estradiol/levonorgestre), Gonadotropin-releasing hormone agonist (Leuprorelin acetate), Add back therapy 1 (tibolone) - Amenorrhea, Endometriosis | Phase 4 | Unknown | University of Cagliari | 50 | 2021-06-01 | 2021-02-04 |
| The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder Tibolone, Estradiol & medroxyprogesterone acetate - Menopausal Syndromes | Phase 4 | Completed | Far Eastern Memorial Hospital | 125 | 2012-11-16 | 2022-02-23 |
| Tibolone and Placebo in Adjunct to Antidepressant Medication for Women With Menopausal Depression Tibolone - Menopausal Depression | Phase 4 | Completed | The Alfred | 120 | 2012-07-01 | 2020-01-09 |
| Investigation of Tibolone and Escitalopram in Perimenopausal Depression Tibolone, Escitalopram, Natvia - Perimenopausal Depression | Phase 4 | Terminated | The Alfred | 2 | 2012-07-01 | 2015-03-31 |
| Vascular Effect of Tibolone in the Brachial Artery Tibolone, Placebo - Menopause | Not applicable | Completed | Selmo Geber | 60 | 2012-03-01 | 2015-04-03 |
| Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery Tibolone, Placebo - Flow-mediated Dilation Evaluation of the Brachial Artery | Not applicable | Completed | Federal University of Minas Gerais | 60 | 2012-02-01 | 2015-04-03 |
| Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study Oxytocin, Oxytocin and Tibolone, Placebo - Depression, Major Depressive Disorder | Phase 1 | Unknown | The Alfred | 15 | 2012-01-01 | 2012-01-18 |
| Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin - Endometriosis | Phase 4 | Unknown | Zhejiang University | 60 | 2008-03-01 | 2011-03-15 |
| Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle), Tibolone (Livial) - Vasomotor Symptoms | Phase 4 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | 204 | 2006-02-01 | 2010-10-29 |
| Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women 17ß-Estradiol/Dydrogesterone, Tibolone - Menopause | Phase 4 | Completed | Solvay Pharmaceuticals | 135 | 2005-11-01 | 2009-04-01 |
| High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone fenofibrate and tibolone, tibolone - HDL Cholesterol | Phase 4 | Completed | Keogh Institute for Medical Research | 20 | 2005-08-01 | 2010-02-02 |
| Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms Black Cohosh (iCR) or tibolone - Menopause | Phase 3 | Completed | Schaper & Bruemmer GmbH & Co KG | 240 | 2004-09-01 | 2006-03-06 |
| Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy Tibolone - Menopause, Postmenopausal Bone Loss | Phase 2 | Completed | Dana-Farber Cancer Institute | 50 | 2004-04-01 | 2007-12-21 |
| Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089) tibolone, estradiol-norethisterone - Sexual Dysfunction | Phase 3 | Completed | Organon and Co | 358 | 2004-03-23 | 2022-02-04 |
| Effects of Tibolone Treatment on the Endometrium Tibolone, Estradiol, Estradiol + Medroxy Progesterone Acetate - Postmenopause, Osteoporosis | Phase 4 | Completed | Erasmus Medical Center | 35 | 2003-02-01 | 2006-02-22 |
| A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469) tibolone, placebo - Breast Cancer | Phase 3 | Completed | Organon and Co | 102 | 2002-12-15 | 2024-08-15 |
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Breast Neoplasms (3) · Depression (3) · Endometriosis (3) · Osteoporosis (2) · Amenorrhea (1) · Bone Diseases, Metabolic (1) · Depressive Disorder, Major (1) · Depressive Disorder, Treatment-Resistant (1) · Leiomyoma (1) · Mental Disorders (1) · Osteoporosis, Postmenopausal (1) · Recurrence (1) · Sexual Dysfunction, Physiological (1) · Sleep Wake Disorders (1)
Organon and Co (7) · The Alfred (3) · Far Eastern Memorial Hospital (2) · Dana-Farber Cancer Institute (1) · Erasmus Medical Center (1) · Federal University of Minas Gerais (1) · Guoqing Zhou (1) · Keogh Institute for Medical Research (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · Peking Union Medical College Hospital (1) · Schaper & Bruemmer GmbH & Co KG (1) · Selmo Geber (1) · Solvay Pharmaceuticals (1) · University of Cagliari (1) · Wyeth is now a wholly owned subsidiary of Pfizer (1)
Australia (4) · China (3) · Brazil (2) · Italy (2) · Taiwan (2) · Canada (1) · Mexico (1) · Netherlands (1) · United States (1)
Jayashri Kulkarni, PhD,FRANZP (2) · Andrew Zakhari, M.D. (1) · Bronwyn G Stuckey, MBBS FRACP (1) · Charlotte Keating, PhD (1) · Curt W Burger, MD, PhD (1) · Gerald F Watts, MD PhD FRACP (1) · Hugh Barrett, BAgSc PhD (1) · Judy Garber, MD, MPH (1) · Leen J Blok, PhD (1) · Rong Chen, Professor (1) · Rosalind Hampton, BSc MBBS (1) · Selmo Geber, MD PhD (1) · Sheng-Mou Hsiao, MD (1)
PMID 17634547, PMID 17995496, PMID 18077316, PMID 18256777, PMID 18304284, PMID 18703472, PMID 19167925, PMID 22030384, PMID 29723767, PMID 30638769, PMID 37619252, PMID 37882059
2004 (1)