MedTrace Logo

Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

NCT05149924 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2021-12-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2019-10-17
Completion
2019-10-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05149924 on ClinicalTrials.gov