NCT04163458

Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)

A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing an Assisted Reproductive Technology Program

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL	Solution for injection in pre-filled pen, subcutaneous administration
DRUG	MENOPUR powder and solvent for solution for injection, 75 IU	Solution for injection in vials (powder and diluent), subcutaneous administration
OTHER	Placebo (for MENOPUR solution for injection in pre-filled pen)	Solution for injection in pre-filled pen, subcutaneous administration
OTHER	Placebo (for MENOPUR powder and solvent for solution for injection)	Solution for injection in vials (powder and diluent); subcutaneous administration

Timeline

• Start date: 2019-10-25
• Primary completion: 2021-05-28
• Completion: 2021-07-16
• First posted: 2019-11-14
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study