Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02150213 | Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492 | PHASE2 | COMPLETED | 59 | — | — | Aug 1, 2014 | Sep 1, 2015 | Dec 5, 2016 | 20 | United States, Germany +4 |
Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
| Arm | Type | Description |
|---|---|---|
| BGG492 | EXPERIMENTAL | This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day |
| Name | Type | Description |
|---|---|---|
| MRI, CT or ultrasound was permitted if MRI was contraindicated | PROCEDURE | MRI/CT/ultrasound of abdomen |
| Dexamethasone Supression Test | PROCEDURE | Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol |
| Sonogram | PROCEDURE | Sonogram of the uterus (females only) |
| Biopsy | PROCEDURE | Uterine endometrial biopsy (females only) |
| BGG492 | DRUG | No study-drug was administered in this study |
Inclusion Criteria: 1. Written informed consent had to be obtained before any assessment was performed; 2. Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;...