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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).

NCT04605107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-27

No results posted yet for this study

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)

Conditions

  • Infertility, Female

Interventions

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

Sponsors & Collaborators

  • EIPICO PHARMA, EGYPT

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-30
Primary Completion
2015-01-08
Completion
2015-03-08

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04605107 on ClinicalTrials.gov