At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 270 enrolled
Drug / intervention
Menotropins +1 moredrug
Likely dose
Menotropins 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.
Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)
In Brief
A Phase 3 clinical trial evaluating Menotropins for Infertility. Completed, enrolled 270 participants across 6 sites in 5 countries.
Detailed Summary
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesDenmark, France, Hungary, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedMar 2011
Primary CompletionApr 2013
Study CompletionDec 2013
TodayJul 2026
First PostedMar 11, 2011
Enrollment StartFeb 1, 2011
Primary CompletionApr 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.3 years ago
Interventions
Menotropinsdrug
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
Menotropinsdrug
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.