Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1002670 · 2 trials · 1 indication
Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.
| Arm | Type | Description |
|---|---|---|
| VPR 4 mg | EXPERIMENTAL | - |
| VPR 2 mg | EXPERIMENTAL | - |
| VPR 1 mg | EXPERIMENTAL | - |
| VPR 0.5 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| BAY1002670 [0.1mg] | EXPERIMENTAL | 0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [0.5mg] | EXPERIMENTAL | 0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [1.0mg] | EXPERIMENTAL | 1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [2.0mg] | EXPERIMENTAL | 2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [5.0mg] | EXPERIMENTAL | 5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| Name | Type | Description |
|---|---|---|
| BAY1002670 | DRUG | Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. |
| Placebo | DRUG | Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. |
Inclusion Criteria: * Signed and dated informed consent * Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm * 18 to 50 years of age at the time of screening * Heavy menstrual bleeding \>80 mL document...
BAY1002670 is an investigational small molecule being developed for leiomyoma, also known as uterine fibroids. It is a Phase 2 drug candidate studied in women with this condition. The drug is not approved and remains in clinical development.
BAY1002670 is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is an investigational small molecule in Phase 2 clinical development for leiomyoma.
BAY1002670 is in Phase 2 clinical development. It has completed two trials, including a Phase 1 study and a Phase 2 study, both in women with leiomyoma. The drug is investigational and not yet approved.
BAY1002670 has completed two clinical trials. NCT01816815 was a Phase 1 study in healthy tubal ligated women evaluating pharmacodynamics, safety, and pharmacokinetics. NCT02131662 was a Phase 2 study of safety and efficacy in women with fibroids across multiple countries.
BAY1002670 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its effects on leiomyoma, or uterine fibroids, in clinical trials.