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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04893798 | A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and Abdomen | PHASE1 | COMPLETED | 67 | — | — | Sep 16, 2021 | Jul 24, 2025 | Aug 14, 2025 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Sayana Press, Upper Arm injection | EXPERIMENTAL | Sayana Press, administered subcutaneously into upper arm |
| Sayana Press, anterior thigh | ACTIVE_COMPARATOR | Sayana Press, administered subcutaneously into anterior thigh |
| Sayana Press, abdomen | ACTIVE_COMPARATOR | Sayana Press, administered subcutaneously into abdomen |
| Name | Type | Description |
|---|---|---|
| Sayana Press | COMBINATION_PRODUCT | Sayana Press is a drug-device combination and is considered a medical product in the EU. |
Inclusion Criteria: * Pre-menopausal female participants, 18 to 45 years of age, inclusive, at the time of signing the ICD who are at low risk of pregnancy * Participants who have a regular menstrual cycle (between 21 and 42 days in length). * No previous injection of depot MPA for 1 year prior to ...