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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00620464 | A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720) | PHASE3 | COMPLETED | 108 | — | — | May 1, 2005 | Feb 1, 2009 | Feb 4, 2022 | - | — |
Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25. AUC0-6months (Area under the curve from zero to six months). AUC0-24months (Area under the curve from zero to 24 months). AUC0-36months (Area under the curve from zero to 36 months).
Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25. Cmax (pg/mL): Peak concentration.
| Arm | Type | Description |
|---|---|---|
| Radiopaque Implanon (ro imp) | ACTIVE_COMPARATOR | The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. |
| Implanon (imp) | ACTIVE_COMPARATOR | Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year. |
| Name | Type | Description |
|---|---|---|
| Radiopaque Implanon | DRUG | Radiopaque rod for 3 years |
| Implanon (etonogestrel implant) | DRUG | Implanon (etonogestrel implant) for 3 years |
Inclusion Criteria: * At least 18 but not older than 40 years of age at the time of screening * Good physical and mental health * Regular cycles with a usual length between 24 and 35 days * Body mass index ≥ 18 and ≤ 29 * Willing to give informed consent in writing Exclusion Criteria: * Contraind...