Clinical Trial

To Study the Safety and Efficacy of A Novel Intrauterine Estrogen-Releasing System in Induced Abortion

Not Yet Recruiting
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Summary
The purpose of this clinical trial is to evaluate the safety and efficacy of the estradiol-loaded silicone rubber intrauterine stent system for promoting endometrial repair after artificial abortion. The main research questions it aims to answer are: 1. Can the estradiol-loaded silicone rubber intrauterine stent system increase the endometrial thickness at 21+2 days after the procedure? 2. What adverse events or safety issues occur in participants when using this product? Researchers will compare the estradiol-loaded silicone rubber intrauterine stent system with a non-drug-loaded silicone intrauterine stent to determine whether the drug-eluting stent offers advantages in promoting endometrial repair. Participants will: 1. Undergo placement of either the estradiol-eluting stent or the non-drug stent immediately after artificial abortion, with the stent retained for 21+2 days 2. Attend scheduled follow-up visits at 21+2 days, after the first menstruation, and at 90 days post-procedure. 3. Undergo ultrasound examinations to measure endometrial thickness, and record vaginal bleeding duration, blood loss volume, time to first menstruation, and any adverse events
Trial Details
NCT Number NCT07381569
Lead Sponsor Peking Union Medical College Hospital
Conditions Abortion, Induced
Enrollment 200 participants
Start Date 2026-03-01
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-02