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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01872078 | A Study of AZD4901 in Females With Polycystic Ovary Syndrome | PHASE2 | COMPLETED | 67 | — | — | Jun 1, 2013 | Jul 1, 2014 | Oct 12, 2015 | 7 | United States, Germany +1 |
Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose \[AUC(0-8)\] at Day 7
| Arm | Type | Description |
|---|---|---|
| AZD4901 20 mg once a day | EXPERIMENTAL | AZD4901 20 mg once a day |
| AZD4901 20mg twice a day | EXPERIMENTAL | AZD4901 20mg twice a day |
| AZD4901 40 mg twice a day | EXPERIMENTAL | AZD4901 40 mg twice a day |
| Placebo to match AZD4901 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZD4901 (oral) | DRUG | Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo |
| Placebo to match AZD4901 | DRUG | Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo |
Inclusion Criteria: Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined as ≤ 6 menses per ye...