Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liquid pergoveris · 1 trial · 1 indication
The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t - (baseline concentration \* t).
The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t - (baseline concentration \* t).
Baseline-corrected Cmax (Cmax,adj) = Cmax - baseline concentration
Baseline-corrected Cmax (Cmax,adj) = Cmax - baseline concentration.
| Arm | Type | Description |
|---|---|---|
| First Liquid Pergoveris, Then Freeze-dried Pergoveris | EXPERIMENTAL | - |
| First Freeze-dried Pergoveris, Then Liquid Pergoveris | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Liquid pergoveris | DRUG | All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period. |
| Freeze-dried pergoveris | DRUG | All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period. |
Inclusion Criteria: * Premenopausal women aged 18 to 40 years (both inclusive) at Screening * Taking a combined oral contraceptive (COCP) for at least 1 year prior to Screening and willing to recommence taking their own COCP from Day 43 of the Marvelon cycle until follow-up * Normal follicle-stimul...