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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04290390 | Annovera™ Drug-Drug Interaction Study | PHASE1 | COMPLETED | 67 | — | — | Feb 12, 2020 | Jan 6, 2021 | Jan 29, 2021 | 1 | Canada |
AUC for 24 hours for segesterone acetate and ethinyl estradiol
Cmax for segesterone acetate and ethinyl estradiol
| Arm | Type | Description |
|---|---|---|
| Annovera (alone) | ACTIVE_COMPARATOR | Annovera taken alone (without itraconazole or rifampin) |
| Annovera with itraconazole use | ACTIVE_COMPARATOR | Subjects will dose with 200 mg/day of itraconazole for five days before Annovera insertion and through Days 1 to 8 of Annovera use |
| Annovera with rifampin use | ACTIVE_COMPARATOR | Subjects will dose with 600 mg/day rifampin for 8 days, between Days 4 to 11 of Annovera use during their respective treatment cycles |
| Name | Type | Description |
|---|---|---|
| Segesterone Acetate and Ethinyl Estradiol | DRUG | Contraceptive Vaginal System |
| Rifampin | DRUG | CYP3A inducer |
| Itraconazole | DRUG | CYP3A inhibitor |
Inclusion Criteria All of the following criteria must be met for the participants to be eligible for the study: * a. Healthy women, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening) sterile or at risk of becoming pregnant, inclusive of ages 18 to 35\* years at ...