A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China

PHASE3CompletedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

March 29, 2024

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
Infertility, Female
Interventions
DRUG

FE 999049

FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants could be treated for a maximum of 20 days.

DRUG

GONAL-F

"GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants could be treated for a maximum of 20 days.~Coasting was not allowed."

Trial Locations (11)

110004

Ferring Investigational Site, Shengyang

201204

Ferring Investigational Site, Shanghai

230032

Ferring Investigational Site, Shushan

300052

Ferring Investigational Site, Tianjin

Ferring Investigational Site, Xiaobailou

330038

Ferring Investigational Site, Nanchang

401147

Ferring Investigational Site, Yuzhong

510000

Ferring Investigational Site, Guangzhou

510120

Ferring Investigational Site, Guangzhou

610041

Ferring Investigational Site, Chengdu

Unknown

Ferring Investigational Site, Zhengzhou

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY