8 completed, 7 terminated, 1 withdrawn. 7 Phase 1, 6 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 6, Terminated 1 |
| Phase 3 | 6 | Terminated 5, Withdrawn 1 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
Follow vilaprisan: new trials by email Literature Review of vilaprisan trials Research Report on vilaprisan
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 |
|---|---|---|---|---|---|---|
| Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Vilaprisan (BAY1002670), Placebo - Uterine Fibroids | Phase 3 | Withdrawn | Bayer | 2018-10-27 | 2020-01-18 | |
| Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis Vilaprisan (BAY1002670), Matching Placebo - Endometriosis | Phase 2 | Terminated | Bayer | 8 | 2018-07-04 | 2022-05-04 |
| A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding Vilaprisan (BAY1002670) - Uterine Fibroids and Heavy Menstrual Bleeding | Phase 3 | Terminated | Bayer | 153 | 2018-03-30 | 2022-07-08 |
| Pharmacokinetics and Safety of Vilaprisan in Renal Impairment Vilaprisan (BAY1002670) - Uterine Fibroids, Endometriosis | Phase 1 | Completed | Bayer | 26 | 2018-02-02 | 2019-12-03 |
| Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4) Vilaprisan (BAY1002670), Placebo - Uterine Fibroids | Phase 3 | Terminated | Bayer | 103 | 2018-01-24 | 2022-06-30 |
| Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3) Vilaprisan (BAY1002670), Placebo - Uterine Fibroids | Phase 3 | Terminated | Bayer | 93 | 2018-01-17 | 2023-05-03 |
| Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned Vilaprisan, BAY1002670, Ulipristal - Leiomyoma | Phase 1 | Terminated | Bayer | 10 | 2017-11-16 | 2021-01-06 |
| A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Vilaprisan (BAY1002670) - Uterine Fibroids | Phase 3 | Terminated | Bayer | 766 | 2017-07-31 | 2024-10-18 |
| Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC) Vilaprisan (BAY 1002670), Vilaprisan Placebo, Microgynon - Clinical Trial ,Phase I | Phase 1 | Completed | Bayer | 71 | 2017-07-17 | 2019-02-28 |
| Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Vilaprisan (BAY1002670), Standard of care - Uterine Fibroids | Phase 3 | Terminated | Bayer | 1272 | 2017-06-30 | 2025-07-28 |
| Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan) Vilaprisan (BAY1002670) - Leiomyoma | Phase 1 | Completed | Bayer | 36 | 2017-03-28 | 2017-08-18 |
| Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan Vilaprisan (BAY1002670), [14C] Vilaprisan, Itraconazole(ITZ) - Clinical Trial, Phase I | Phase 1 | Completed | Bayer | 14 | 2015-07-01 | 2016-03-02 |
| Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids Vilaprisan (BAY1002670), Vilaprisan (BAY1002670, Ulipristal - Leiomyoma | Phase 2 | Completed | Bayer | 120 | 2015-06-01 | 2016-11-22 |
| Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan Vilaprisan (BAY1002670) - Clinical Trial, Phase I | Phase 1 | Completed | Bayer | 70 | 2014-10-01 | 2016-03-16 |
| Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap BAY1002670, Placebo - Leiomyoma | Phase 2 | Completed | Bayer | 309 | 2014-05-15 | 2017-12-08 |
| Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670 BAY1002670, Placebo - Leiomyoma | Phase 1 | Completed | Bayer | 73 | 2011-11-01 | 2014-04-21 |
Leiomyoma (12) · Menorrhagia (4) · Endometriosis (2)
Bayer (16)
Czechia (7) · Germany (7) · Japan (6) · United States (6) · Finland (5) · United Kingdom (5) · Belgium (4) · Bulgaria (4) · Norway (4) · Poland (4) · Austria (3) · Canada (3) · Hungary (3) · Italy (3) · Spain (3)
PMID 27288475, PMID 29330782, PMID 30527839, PMID 30682081, PMID 32559602, PMID 37437885, PMID 38983729, PMID 41059527
2016 (4), 2014 (3), 2017 (2), 2015 (1)