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Also known as Livial®, OD-14
tibolone · 5 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | tibolone |
| 2 | ACTIVE_COMPARATOR | transdermal continuous combined E2-NETA (estradiol-norethisterone) |
| Arm 1 | ACTIVE_COMPARATOR | Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with tibolone |
| Arm 2 | PLACEBO_COMPARATOR | Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with placebo |
| Tibolone | ACTIVE_COMPARATOR | Tibolone 2.5 mg/day |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Tibolone 1.25 mg | EXPERIMENTAL | - |
| Tibolone 2.5 mg | EXPERIMENTAL | - |
| CE/MPA | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| tibolone | DRUG | tibolone (2.5 mg) over 24 weeks |
| estradiol-norethisterone | DRUG | transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks |
| placebo | DRUG | Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery). |
| Tibolone 2.5 mg | DRUG | oral 2.5 mg tablet, once daily, for 2 years |
| CE/MPA | DRUG | oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years |
Inclusion Criteria: * Physically and mentally healthy postmenopausal women, \>=48 and \<=68 years of age, with an intact uterus. * Women were to suffer from decreased satisfactory sexual activity compared to younger age and sexual problems were not to be considered caused by relationship/partner pr...
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Tibolone is a small molecule drug developed by Organon & Co. (ticker OGN). It has been studied in Phase 3 clinical trials for several conditions affecting women, including breast cancer, osteoporosis, sexual dysfunction, and use in postmenopausal women. It is a synthetic steroid that acts on multiple tissues.
Tibolone has been investigated in Phase 3 trials for osteoporosis in women aged 60 and older, for breast tissue effects in postmenopausal women with breast cancer, for sexual dysfunction in naturally postmenopausal women, and for endometrial effects in postmenopausal women. These studies are completed, and tibolone remains an investigational agent in these programs.
Tibolone is developed by Organon & Co., which trades under the ticker OGN. Organon sponsored the Phase 3 clinical program evaluating tibolone across breast cancer, osteoporosis, sexual dysfunction, and postmenopausal women indications.
Tibolone is in Phase 3 clinical development. Its Phase 3 trials are completed, and no active trials are currently listed. Tibolone is investigational and has not been established as approved for the indications studied in this program.
Tibolone has been studied in completed Phase 3 trials including NCT00745108 in postmenopausal women, NCT00725374 in postmenopausal women with breast cancer, NCT00519857 in osteoporosis, and NCT00413764 comparing tibolone with transdermal E2/NETA for sexual function in naturally postmenopausal women. All four trials are completed.
The tibolone Phase 3 program enrolled a total of 4,534 participants across its trials. The largest study, NCT00519857 in osteoporosis, enrolled 4,534 women aged 60 and older. The trials were randomized, double-blind, and placebo-controlled, with some biomarker-selected patient populations.