At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 373 enrolled
Drug / intervention
Follitropin delta +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 Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme
In Brief
A Phase 3 clinical trial evaluating Follitropin delta and Follitropin beta for Infertility. Completed, enrolled 373 participants across 17 sites.
Detailed Summary
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartJul 2017
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedJul 25, 2017
Enrollment StartJul 29, 2017
Primary CompletionJun 10, 2019
Study CompletionJul 8, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.9 years ago
Interventions
Follitropin deltadrug
Single daily subcutaneous administration through pre-filled injection pen
Follitropin betadrug
Single daily subcutaneous injection in the abdomen