Trials / Completed
CompletedNCT05149924
Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
A Multicenter, Randomized, Single-blind, Active-controlled, Phase III Clinical Study to Compare the Efficacy and Safety of QL1012(Recombinant Human Follicle-stimulating Hormone) and Gonal-f ® in Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Treatment
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 354 (actual)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years – 39 Years
- Healthy volunteers
- Not accepted
Summary
The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL1012 | Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU |
| DRUG | Gonal-f ® | Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU |
Timeline
- Start date
- 2018-10-31
- Primary completion
- 2019-10-17
- Completion
- 2019-10-17
- First posted
- 2021-12-08
- Last updated
- 2021-12-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05149924. Inclusion in this directory is not an endorsement.