Trials / Completed
CompletedNCT03296527
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Pan-Asian Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology Programme
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,011 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 20 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Follitropin alfa | GONAL-F dose was fixed for the first 5 stimulation days. |
| DRUG | Follitropin delta | REKOVELLE (FE 999049) was fixed throughout the stimulation period. |
Timeline
- Start date
- 2017-12-01
- Primary completion
- 2020-01-03
- Completion
- 2020-07-26
- First posted
- 2017-09-28
- Last updated
- 2023-08-24
- Results posted
- 2021-06-01
Locations
26 sites across 4 countries: China, South Korea, Taiwan, Vietnam
Source: ClinicalTrials.gov record NCT03296527. Inclusion in this directory is not an endorsement.