At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,011 enrolled
Drug / intervention
Follitropin alfa +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.
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Pan-Asian Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology Programme
In Brief
A Phase 3 clinical trial evaluating Follitropin alfa and Follitropin delta for Controlled Ovarian Simulation. Completed, enrolled 1,011 participants across 26 sites in 4 countries.
Detailed Summary
To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsControlled Ovarian Simulation
CountriesChina, South Korea, Taiwan, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartDec 2017
Primary CompletionJan 2020
Study CompletionJul 2020
TodayJul 2026
First PostedSep 28, 2017
Enrollment StartDec 1, 2017
Primary CompletionJan 3, 2020
Study CompletionJul 26, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.8 years ago
Interventions
Follitropin alfadrug
GONAL-F dose was fixed for the first 5 stimulation days.
Follitropin deltadrug
REKOVELLE (FE 999049) was fixed throughout the stimulation period.