At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 118 enrolled
Drug / intervention
Follitropin alfa (Gonal-f) +1 moredrug
Likely dose
Follitropin alfa (Gonal-f) 150 IUfrom 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.
Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
In Brief
A Phase 3 clinical trial evaluating Follitropin alfa (Gonal-f) and Follitropin alfa (Primapur) for Infertility, Female. Completed, enrolled 118 participants across 3 sites.
Detailed Summary
The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Female
CountriesRussia
CollaboratorsBridgePharm LLC, GlobalPharma LLC
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartFeb 2017
First PostedMar 2017
Primary CompletionAug 2018
TodayJul 2026
First PostedMar 23, 2017
Enrollment StartFeb 8, 2017
Primary CompletionAug 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.3 years ago
Interventions
Follitropin alfa (Gonal-f)drug
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Primapur)drug
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation