302
Participants
Start Date
July 15, 2022
Primary Completion Date
April 16, 2024
Study Completion Date
April 16, 2024
REKOVELLE (Follitropin Delta)
REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the participant's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Participants could be treated for a maximum of 20 days.
GONAL-F (Follitropin Alfa)
GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the participant's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Participants could be treated for a maximum of 20 days.
Ferring Investigational Site, Wals-Seizenheim
Ferring Investigational Site, Vienna
Ferring Investigational Site, Montpellier
Ferring Investigational Site, Paris
Ferring Investigational Site, Florence
Ferring Investigational Site, Milan
Ferring Investigational Site, Napoli
Ferring Investigational Site, Roma
Ferring Investigational Site, Alicante
Ferring Investigational Site, Barcelona
Ferring Investigational Site, Bilbao
Ferring Investigational Site, Madrid
Ferring Investigational Site, Málaga
Ferring Investigational Site, Valladolid
Ferring Investigational Site, Coventry
Ferring Investigational Site, Liverpool
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY