NCT04605107

Biosimilarity Study of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA).

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 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. 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.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
DRUG	Epifasi: Human chorionic gonadotrophin	IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
DRUG	Pregnyl: Human chorionic gonadotrophin	IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin

Timeline

• Start date: 2013-08-30
• Primary completion: 2015-01-08
• Completion: 2015-03-08
• First posted: 2020-10-27
• Last updated: 2020-10-27

Locations

1 site across 1 country: Egypt