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)
Recruiting
Phase 3
Interventional Study
Infertility
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 42
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 266 (estimated)
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants who are premenopausal wishing to conceive
* Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
* Japanese Participants
* Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormon…
Contacts