At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 460 enrolled
Drug / intervention
Follitropin alfadrug
Likely dose
Follitropin alfa 150IUfrom 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.
A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment
In Brief
A Phase 3 clinical trial evaluating Follitropin alfa for Infertility. Completed, enrolled 460 participants across 16 sites in 6 countries.
Detailed Summary
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesAustria, Denmark, Germany, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJun 2010
Primary CompletionDec 2011
Study CompletionMar 2013
TodayJul 2026
First PostedMay 12, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2011
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.1 years ago
Interventions
Follitropin alfadrug
150IU per day subcutaneously for a maximum of 16 days