Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899193
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2021-05-19
Brief Title:
Pergoveris FD and Liquid China BE Study
Sponsor:
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
Organization:
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Phase I Open-label Randomized Three-period Crossover Single-center Trial to Assess the Bioequivalence of the Co-administration of 900 IU of Follitropin Alfa Gonal-f and 450 IU of Lutropin Alfa Luveris Versus the Fixed Combination of 900 IU Follitropin Alfa and 450 IU Lutropin Alfa in Pergoveris Administered SC as Liquid and FD Formulation in Pituitary Suppressed Healthy Premenopausal Female Chinese Participants
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to assess the bioequivalence BE of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried FD Test 1 or in Pergoveris Liquid Test 2 versus the co-administration of Gonal-f and Luveris Reference administered subcutaneously SC in pituitary suppressed healthy premenopausal Chinese female participants at the doses of 900 international unit IU of follitropin alfa and 450 IU lutropin alfa
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None