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 developed by Merck KGaA. It has been studied in a Phase 1 clinical trial in healthy female volunteers in China. The specific therapeutic indication for Pergoveris FD has not been disclosed.
Pergoveris FD is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the clinical study of Pergoveris FD conducted in China.
Pergoveris FD is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.
Pergoveris FD has been evaluated in one completed Phase 1 trial, NCT04899193, titled Pergoveris FD and Liquid China BE Study. The trial enrolled 72 healthy female volunteers aged 18 years and older in China and used a controlled, randomized design.
No. Pergoveris FD is an investigational drug in Phase 1 clinical development and is not FDA approved. Its only recorded trial, NCT04899193, has been completed, and no active trials are ongoing.