NCT04773353

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial in India Comparing the Efficacy and Safety of FE 999049 (Follitropin Delta) With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Follitropin Delta (FE 999049)	FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. For participants with low AMH (\<15 pmol/L) the daily FE 999049 dose was 12 μg, irrespective of body weight. For participants with high AMH (≥15 pmol/L) the daily FE 999049 dose was on a continuous scale ranging from 0.19 to 0.10 μg/kg, i.e. dependent on actual AMH and body weight. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Participants could be treated for a maximum of 20 days.
DRUG	Follitropin Alfa (GONAL-F)	GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Participants could be treated for a maximum of 20 days.

Timeline

• Start date: 2021-12-03
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2021-02-26
• Last updated: 2025-01-24

Locations

12 sites across 1 country: India