A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating
hormone (FSH) and luteinizing hormone (LH) activity. Human chorionic gonadotrophin (hCG) is
the major contributor to the LH activity in the product. MENOPUR is approved in more than 130
countries for a variety of strengths and indications. In China, MENOPUR, 75 IU is approved
for controlled ovarian hyperstimulation in relation to assisted reproductive technology
(ART). The current trial is intended for supporting marketing authorization approval of a new
formulation of MENOPUR in China.
MENOPUR is currently available in China as a powder and solvent for solution for injection,
containing 75 IU of FSH and 75 IU of LH activity. A new liquid formulation is developed by
Ferring Pharmaceuticals for administration with a disposable pre-filled injection pen,
containing 600 IU of FSH and 600 IU of LH activity. MENOPUR solution for injection in
pre-filled pen, 600 IU/0.96 mL is the test product and MENOPUR powder and solvent for
solution for injection, 75 IU is the reference product in this trial.