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Radiopaque Implanon · 1 trial · 1 indication
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...
Radiopaque Implanon is an investigational contraceptive implant being developed for contraception. It is a small molecule product in Phase 3 clinical development. The drug is designed to provide long-acting birth control, though it is not yet approved and remains under investigation.
Radiopaque Implanon is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker OGN. The company is conducting clinical trials to evaluate the safety and efficacy of this contraceptive implant.
Radiopaque Implanon is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the product is being studied for use in contraception.
Radiopaque Implanon has one completed Phase 3 clinical trial registered as NCT00620464. The study, titled "A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)," enrolled 108 healthy female participants aged 18 years and older. The trial was randomized, double-blind, and active-controlled.
Radiopaque Implanon is a version of the contraceptive implant Implanon that has been made radiopaque, meaning it is visible under X-ray. The Phase 3 trial NCT00620464 was designed as a bioequivalence study comparing Radiopaque Implanon to the standard Implanon product.