drugset / Trial / NCT01735422
A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a single center, open-label, randomized, parallel group, dose finding study to evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®), compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).
Timeline
- Start
- 1999-12
- Primary completion
- 2001-07
- Completion
- 2001-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | r-hLH | Protein / enzyme biologic | 825 iu | Subcutaneous |
| Subject | r-hLH | Protein / enzyme biologic | 2750 iu | Subcutaneous |
| Subject | r-hLH | Protein / enzyme biologic | 5500 iu | Subcutaneous |
| Subject | r-hLH | Protein / enzyme biologic | 11000 iu | Subcutaneous |
| Subject | r-hLH | Protein / enzyme biologic | 22000 iu | Subcutaneous |
| Comparator | u-hCG | Protein / enzyme biologic | 5000 iu | Subcutaneous |
| Background | Gonal-f | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Background | Gonal-f | Protein / enzyme biologic | 225 iu | Subcutaneous |