CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Epifasi: Human chorionic gonadotrophin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04605107
NCT04605107Phase 4Completed
CompareCT.gov

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)

Genuine Research Center, Egypt·interventional·Posted Oct 27, 2020·Updated Oct 27, 2020

In Brief

A Phase 4 clinical trial evaluating Epifasi: Human chorionic gonadotrophin and Pregnyl: Human chorionic gonadotrophin for Infertility, Female. Completed, enrolled 60 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Female
CountriesEgypt
CollaboratorsEIPICO PHARMA, EGYPT

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 27, 2020
Enrollment StartAug 30, 2013
Primary CompletionJan 8, 2015
Study CompletionMar 8, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.7 years ago

Interventions

Epifasi: Human chorionic gonadotrophindrug

IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin

Pregnyl: Human chorionic gonadotrophindrug

IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin