drugset / Trial / NCT01599494
An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study, conducted in India, will be recruiting women participants who are between the ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell) production after administration of the investigative drug, MK-8962 (corifollitropin alfa) + recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference drug, recFSH.
Timeline
- Start
- 2014-03
- Primary completion
- 2015-05
- Completion
- 2015-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 150 ug | Subcutaneous |
| Subject | Follitropin beta | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Subject | Follitropin beta | Protein / enzyme biologic | 300 iu | Subcutaneous |
| Background | Ganirelix | Protein / enzyme biologic | 0.25 mg | Subcutaneous |
| Background | Progesterone | Other / unclassified | 90 mg | Other |
| Background | human chorionic gonadotropin | Protein / enzyme biologic | 5000 iu | Subcutaneous |
| Background | human chorionic gonadotropin | Protein / enzyme biologic | 10000 iu | Subcutaneous |