drugset / Trial / NCT07340827
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Phase 3
Recruiting
266 enrolled
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART). The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.
Timeline
- Start
- 2026-02-05
- Primary completion
- 2028-07-05
- Completion
- 2028-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonal-f | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Subject | Luveris | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Comparator | hMG | Unknown | 150 iu | Subcutaneous |
| Background | Cetrorelix | Other / unclassified | 250 ug | — |
| Background | Coriogonadotropin alfa | Unknown | 250 ug | Subcutaneous |
| Background | Progesterone | Other / unclassified | 90 mg | Other |