MedTrace Logo

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects

NCT05994378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2025-09-15

No results posted yet for this study

Summary

This study is a multi-center, randomized, double-blind, positive drug-controlled, non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.

Conditions

  • Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation

Interventions

DRUG

SHR7280；Ganirelix Acetate Injection simulant

SHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd;

DRUG

SHR7280 simulant； Ganirelix Acetate Injection

SHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd;

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2025-05-02
Completion
2025-05-02

Countries

  • China

Study Locations

More Related Trials

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 NCT05994378 on ClinicalTrials.gov