drugset / Trial / NCT00697255
A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.
Timeline
- Start
- 2007-05-15
- Primary completion
- 2008-04-03
- Completion
- 2008-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 15 ug | Subcutaneous |
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 20 ug | Subcutaneous |
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 30 ug | Subcutaneous |
| Subject | Follitropin beta | Protein / enzyme biologic | 50 iu | Subcutaneous |
| Subject | Follitropin beta | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Subject | human chorionic gonadotropin | Protein / enzyme biologic | 200 iu | Subcutaneous |
| Subject | human chorionic gonadotropin | Protein / enzyme biologic | 5000 iu | Subcutaneous |