Pergoveris FD and Liquid China BE Study

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

May 8, 2021

Primary Completion Date

May 28, 2022

Study Completion Date

May 28, 2022

Conditions
Healthy
Interventions
DRUG

Pergoveris FD

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.

DRUG

Pergoveris Liquid

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.

DRUG

Gonal-f

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.

DRUG

Luveris

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.

Trial Locations (1)

100053

Xuanwu Hospital, Capital Medical University, Beijing

All Listed Sponsors
lead

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY