drugset / Trial / NCT00553514
AS900672-Enriched in Ovulation Induction
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.
Timeline
- Start
- 2007-12
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AS900672-Enriched | Protein / enzyme biologic | 10 ug | Subcutaneous |
| Subject | AS900672-Enriched | Protein / enzyme biologic | 20 ug | Subcutaneous |
| Subject | AS900672-Enriched | Protein / enzyme biologic | 30 ug | Subcutaneous |
| Subject | AS900672-Enriched | Protein / enzyme biologic | 40 ug | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Background | Ovidrel | Protein / enzyme biologic | 250 ug | Subcutaneous |