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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04291001 | Ovarian Function With ENG Implant and UPA Use | EARLY_PHASE1 | COMPLETED | 40 | — | — | Sep 4, 2020 | Jan 12, 2024 | Jul 12, 2024 | 1 | United States |
Ovulation will be monitored by ultrasound and serum LH and progesterone levels
Ovulation will be monitored by ultrasound and serum LH and progesterone levels
| Arm | Type | Description |
|---|---|---|
| ENG Implant alone | ACTIVE_COMPARATOR | Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. |
| ENG Implant plus oral UPA | ACTIVE_COMPARATOR | Participants will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. |
| Name | Type | Description |
|---|---|---|
| ENG implant | DEVICE | This is an FDA-approved contraceptive device |
| oral ulipristal acetate | DRUG | This is an FDA-approved oral emergency contraceptive |
Inclusion Criteria: * Healthy females, age 18-35 * Fluent in English * BMI \< 30 kg/m2 * No known contraindication to either the ENG contraceptive implant or Ulipristal Acetate (UPA) using the CDC Medical Eligibility Criteria for Contraceptive Use 2016 * Not current pregnant and not at risk of preg...