Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04605107
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2020-09-22
Brief Title:
Biosimilarity Study of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 IU Ampoules EIPICO PHARMA EGYPT and Treatment B REFERENCE Product Pregnyl 5000 IU Ampoules Baxter Pharmaceutical Solutions for Organon USA
Sponsor:
Genuine Research Center Egypt
Organization:
Genuine Research Center Egypt
Study Overview
Official Title:
Comparative Randomized Single Dose Parallel Triple-blinded Study in Infertile Females to Evaluate Biosimilarity of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 IU Ampoules EIPICO PHARMA EGYPT and Treatment B REFERENCE Product Pregnyl 5000 IU Ampoules Baxter Pharmaceutical Solutions for Organon USA
Status:
COMPLETED
Status Verified Date:
2020-09
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:
Comparative randomized single dose parallel triple-blinded study in infertile females to evaluate biosimilarity of IM Injection of Human Chorionic Gonadotrophin HCG after Parenteral administration of Treatment A TEST Product Epifasi 5000 IU Ampoules EIPICO PHARMA EGYPT and Treatment B REFERENCE Product Pregnyl 5000 IU Ampoules Baxter Pharmaceutical Solutions for Organon USA
Detailed Description:
In this study the biosimilarity of Human chorionic gonadotropin HCG from Epifasi IM Injection EIPICO Pharma Egypt and Pregnyl IM Injection Baxter Pharmaceutical Solutions for Organon USA after a single IM dose administration of each to healthy adult will be investigated to determining the study variables Ovarian Ultrasonic counting mature grafian follicles Number of retrieved oocytes and their grades
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