To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®

NCT ID: NCT03051087

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-03-31

Brief Summary

to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies

Conditions

Controlled Ovarian Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ganilever (ganirelix acetate)

Prefilled syringe / 0.25mg/0.5mL

Group Type: EXPERIMENTAL

Ganirelix acetate

Intervention Type: DRUG

Orgalutran (ganirelix acetate)

Prefilled syringe / 0.25mg/0.5mL

Group Type: ACTIVE_COMPARATOR

Ganirelix acetate

Intervention Type: DRUG

Interventions

Ganirelix acetate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• An adult female between the ages of 20 and 39 at the time of screening
• Patients whose mean menstrual cycle was between 25 and 35 days
• Patients whose FSH (follicle stimulating hormone) concentration does not exceed 13 mIU / mL at screening
• Patients diagnosed with infertility due to one or more of the following A. Trouble Factors B. Male Factors C. Unexplained D. Uterine factors
• Patients with previous IVF experience less than 3
• Patient who signed the written consent after hearing the explanation of the purpose, method and effect of the clinical trial

Exclusion Criteria

• If the sperm donor (spouse or non-spouse) is a severe male factor (Non obstructive azoospermia)
• Patients who were diagnosed as PCOS (polycystic ovary syndrome) during screening
• Patient with abnormal uterine bleeding during screening
• Patients diagnosed with primary ovarian failure
• Patients who has ovarian cysts that are not related to PCOS during screening
• Patients with tubal hydrops
• Patients with untreated non-reproductive endocrine disease
• Patients with a deformity of the reproductive organs that can not be conceived, or fibroids of the uterus that can not be conceived (only for submucosal myoma)
• Patients with less than 2 ovaries (0 or1)
• Patients with ovarian, breast, uterus, hypothalamus, or pituitary malignancies
• Patients with BMI <18 or BMI> 30
• Patients with an LH concentration of less than 1.2mIU / mL during screening
• Poor ovarian responder by bologna criteria
• Patients with moderate or severe renal impairment (creatinine clearance <60 mL / min) or liver function impairment (ALT or AST,> 5 times normal)
• Patients who experienced Grade 4 or higher OHSS (ovarian hyperstimulation syndrome) before
• Patients who are contraindicated for pregnancy
• Patients being pregnant or lactating
• Patients with hypersensitivity to IP
• Patients who have participated in other medication-related clinical trials since enrollment in this study, or have participated in other clinical trials within 3 months (90 days) before enrolling in this trial

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHA Bundang Medical Center, CHA University

Gyeonggi-do, , South Korea

CHA Gangnam Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LG-GNCL001

Identifier Type: -

Identifier Source: org_study_id