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...
Liquid pergoveris is an investigational small molecule being studied for use in healthy premenopausal female subjects. It is being developed as a liquid formulation of pergoveris, a medication used in fertility treatments. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Liquid pergoveris is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and bioequivalence of this liquid formulation compared to the freeze-dried version of pergoveris.
Liquid pergoveris is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 34 healthy premenopausal female subjects in Germany. The drug is investigational and has not received FDA approval. It remains in early-stage clinical testing to assess its pharmacokinetic profile and bioequivalence.
Liquid pergoveris has one completed clinical trial registered under NCT02317809, titled "Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects." This Phase 1 study enrolled 34 healthy female participants aged 18 years and older in Germany and was a controlled, randomized trial.
Liquid pergoveris is a liquid formulation of pergoveris, which is also available as a freeze-dried product. The two forms contain the same active ingredients but differ in their pharmaceutical formulation. The clinical trial NCT02317809 was designed to compare the bioequivalence of the liquid version against the freeze-dried version in healthy premenopausal women.