8 completed, 3 unknown, 1 terminated. 12 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 12 | Completed 8, Unknown 3, Terminated 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®) tibolone, low-dose estradiol/noresterone - Menopause | Phase 4 | Completed | Organon and Co | 570 | 2002-11-01 | 2022-02-03 |
| Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090) tibolone, raloxifen - Osteopenia | Phase 4 | Completed | Organon and Co | 324 | 2000-07-31 | 2024-08-15 |
Depression (2) · Endometriosis (2) · Amenorrhea (1) · Bone Diseases, Metabolic (1) · Osteoporosis (1) · Recurrence (1) · Sleep Wake Disorders (1)
Organon and Co (2) · The Alfred (2) · Erasmus Medical Center (1) · Far Eastern Memorial Hospital (1) · Keogh Institute for Medical Research (1) · Peking Union Medical College Hospital (1) · Solvay Pharmaceuticals (1) · University of Cagliari (1) · Wyeth is now a wholly owned subsidiary of Pfizer (1) · Zhejiang University (1)
Australia (3) · Italy (2) · China (1) · Mexico (1) · Netherlands (1) · Taiwan (1)
Jayashri Kulkarni, PhD,FRANZP (2) · Bronwyn G Stuckey, MBBS FRACP (1) · Curt W Burger, MD, PhD (1) · Gerald F Watts, MD PhD FRACP (1) · Hugh Barrett, BAgSc PhD (1) · Leen J Blok, PhD (1) · Rong Chen, Professor (1) · Rosalind Hampton, BSc MBBS (1) · Xinmei Zhang, Prof. (1)
PMID 17995496, PMID 18077316, PMID 18256777, PMID 29723767, PMID 37882059
2004 (1)