drugset / Trial / NCT01653743
Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-11
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MSJ-0011 | Protein / enzyme biologic | 250 ug | Subcutaneous |
| Comparator | human chorionic gonadotropin | Protein / enzyme biologic | 5000 iu | Intramuscular |
| Background | Gonal-f | Protein / enzyme biologic | 75 iu | Subcutaneous |