CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,100 enrolled
Drug / intervention
AFOLIA +1 moredrug
Likely dose
AFOLIA 225IUfrom 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/NCT01687712
NCT01687712Phase 3Completed
CompareCT.gov

Phase III Investigator and Assessor Blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA vs Gonal-f® RFF) in Normal Ovulatory Women 35 to 42 Years Old Undergoing in Vitro Fertilization

Fertility Biotech AG·interventional·Posted Sep 19, 2012·Updated Dec 5, 2017

In Brief

A Phase 3 clinical trial evaluating AFOLIA and Gonal-f® RFF for Infertility. Completed, enrolled 1,100 participants across 22 sites.

Detailed Summary

The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2012
Enrollment StartNov 25, 2013
Primary CompletionSep 10, 2015
Study CompletionNov 14, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.8 years ago

Interventions

AFOLIAdrug

225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached

Gonal-f® RFFdrug

225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached