At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 437 enrolled
Drug / intervention
FE 999049 + GnRH agonist (GONAPEPTYL) +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, Open Label, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of Individualised FE 999049 (Follitropin Delta) Dosing, Using a Long GnRH Agonist Protocol and a GnRH Antagonist Protocol in Women Undergoing Controlled Ovarian Stimulation
In Brief
A Phase 3 clinical trial evaluating FE 999049 + GnRH agonist (GONAPEPTYL) and FE 999049 + GnRH antagonist (CETROTIDE) for Infertility, Female. Completed, enrolled 437 participants across 16 sites in 7 countries.
Detailed Summary
To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone (GnRH) agonist protocol versus a short GnRH antagonist protocol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Female
CountriesAustria, Denmark, Israel, Italy, Netherlands, Norway, Switzerland
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartApr 2019
Primary CompletionFeb 2022
TodayJul 2026
First PostedJan 18, 2019
Enrollment StartApr 29, 2019
Primary CompletionFeb 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.5 years ago
Interventions
FE 999049 + GnRH agonist (GONAPEPTYL)drug
Pre-filled injection pen
FE 999049 + GnRH antagonist (CETROTIDE)drug
Powder and solvent for solution for injection