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Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

NCT05082233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-02-20

No results posted yet for this study

Summary

This study is a multicentre, open-label phase II dose-finding clinical trial that will recruit approximately 120 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). We set up three SHR7280 tablets dose groups of 300 mg BID, 200 mg BID, and 200 mg QD with 40 subjects in each group, besides, a group of 400mg bid is set as an alternative.

Conditions

  • Female Subjects Undergoing COH in ART to Prevent Early Ovulation

Interventions

DRUG

SHR7280 tablets

Treatment group A:SHR7280 tablets ; 300mg BID； Treatment group B:SHR7280 tablets ; 200mg BID； Treatment group C:SHR7280 tablets ; 200mg QD； Treatment group D:SHR7280 tablets ; 400mg BID；

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-03-06
Primary Completion
2023-08-03
Completion
2023-08-03

Countries

  • China

Study Locations

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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 NCT05082233 on ClinicalTrials.gov