NCT04902131

A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women

An Open-label, Randomised, 2-way Crossover, Single-dose, Bioequivalence Trial Comparing MENOPUR Solution for Injection in Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection, After Subcutaneous Administration in Healthy Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
DRUG	A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL	Single dose cross-over bioequivalence trial
DRUG	A MENOPUR powder including solvent for solution for injection, 75 IU	Single dose cross-over bioequivalence trial

Timeline

• Start date: 2021-11-02
• Primary completion: 2022-08-15
• Completion: 2022-08-15
• First posted: 2021-05-26
• Last updated: 2022-08-24

Locations

2 sites across 1 country: China