Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pergoveris FD · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1: First Reference, Then Test 1, Then Test 2 | EXPERIMENTAL | Participants will receive single dose of Reference drug (Gonal-f/Luveris injection) on Day 1 in investigation period 1 followed by Test 1 drug (Pergoveris FD) on Day 1 in investigation period 2 followed by Test 2 drug (Pergoveris Liquid) on Day 1 in investigation period 3. A washout period of 6 days will be maintained between period 1 and 2 and washout period of 17 days will be maintained between period 2 and 3. |
| Sequence 2: First Test 1, Then Test 2, Then Reference | EXPERIMENTAL | Participants will receive single dose of Test 1 drug (Pergoveris FD) on Day 1 in investigation period 1 followed by Test 2 drug (Pergoveris Liquid) on Day 1 in investigation period 2 followed by Reference drug (Gonal-f/Luveris injection) on Day 1 in investigation period 3. A washout period of 6 days will be maintained between period 1 and 2 and washout period of 17 days will be maintained between period 2 and 3. |
| Sequence 3: First Test 2, Then Reference, Then Test 1 | EXPERIMENTAL | Participants will receive single dose of Test 2 drug (Pergoveris Liquid) on Day 1 in investigation period 1 followed by Reference drug (Gonal-f/Luveris injection) on Day 1 in investigation period 2 followed by Test 1 drug (Pergoveris FD) on Day 1 in investigation period 3. A washout period of 6 days will be maintained between period 1 and 2 and washout period of 17 days will be maintained between period 2 and 3. |
| Sequence 4: First Reference, Then Test 2, Then Test 1 | EXPERIMENTAL | Participants will receive single dose of Reference drug (Gonal-f/Luveris injection) on Day 1 in investigation period 1 followed by Test 2 drug (Pergoveris Liquid) on Day 1 in investigation period 2 followed by Test 1 drug (Pergoveris FD) on Day 1 in investigation period 3. A washout period of 6 days will be maintained between period 1 and 2 and washout period of 17 days will be maintained between period 2 and 3. |
| Sequence 5: First Test 1, Then Reference, Then Test 2 | EXPERIMENTAL | Participants will receive single dose of Test 1 drug (Pergoveris FD) on Day 1 in investigation period 1 followed by Reference drug (Gonal-f/Luveris injection) on Day 1 in investigation period 2 followed by Test 2 drug (Pergoveris Liquid) on Day 1 in investigation period 3. A washout period of 6 days will be maintained between period 1 and 2 and washout period of 17 days will be maintained between period 2 and 3. |
| Sequence 6: First Test 2, Then Test 1, Then Reference | EXPERIMENTAL | Participants will receive single dose of Test 2 drug (Pergoveris Liquid) on Day 1 in investigation period 1 followed by Test 1 drug (Pergoveris FD) on Day 1 in investigation period 2 followed by Reference drug (Gonal-f/Luveris injection) on Day 1 in investigation period 3. A washout period of 6 days will be maintained between period 1 and 2 and washout period of 17 days will be maintained between period 2 and 3. |
| Name | Type | Description |
|---|---|---|
| Pergoveris FD | DRUG | Participants will be administered with 900 IU of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3. |
| Pergoveris Liquid | DRUG | Participants will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Pergoveris Liquid) as subcutaneous injection using disposable pen-injector on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3. |
| Gonal-f | DRUG | Participants will be administered with 900 IU of folitropin alfa (Gonal-f) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3. |
| Luveris | DRUG | Participants will be administered with 450 IU of lutropin alfa (Luveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3. |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and ECG, blood pressure (systolic and diastolic) and pulse rate * Participants who have a negative serum pregnancy test before starting ...
Pergoveris FD is an investigational small molecule being studied in healthy female volunteers. It is currently in Phase 1 clinical development, with a completed trial in China. The drug is being evaluated for its effects in healthy individuals, though its specific therapeutic indication has not been established.
Pergoveris FD is being developed by Merck KGaA, a biopharmaceutical company. The company's stock is traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.
Pergoveris FD is in Phase 1 clinical development. It has one completed trial, NCT04899193, which enrolled 72 healthy female volunteers in China. The drug is investigational and has not been approved by regulatory authorities.
Pergoveris FD has one completed Phase 1 trial, NCT04899193, titled "Pergoveris FD and Liquid China BE Study." This trial enrolled 72 healthy female participants aged 18 years and older in China. The study was controlled and randomized, though not double-blinded.
Pergoveris FD is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial, NCT04899193, was conducted in healthy volunteers in China, and the drug has not yet progressed to later-stage trials or regulatory submission.