drugset / Trial / NCT00328926

Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])

NCT00328926

Phase 4 Terminated 11 enrolled EMD Serono
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.

Timeline

Start
2006-03
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Luveris Protein / enzyme biologic 25 iu Subcutaneous
Comparator Luveris Protein / enzyme biologic 75 iu Subcutaneous
Comparator Gonal-f Protein / enzyme biologic 75 iu Subcutaneous
Comparator Gonal-f Protein / enzyme biologic 150 iu Subcutaneous
Comparator Gonal-f Protein / enzyme biologic 225 iu Subcutaneous
Comparator Ovidrel Protein / enzyme biologic 250 ug Subcutaneous