NCT07381569

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

A Clinical Study on the Safety and Efficacy of Estradiol-Loaded Silicone Rubber Intrauterine Stent System for Promoting Endometrial Repair After Induced Abortion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Conditions

• Abortion, Induced

Interventions

Type	Name	Description
DEVICE	Estradiol-Loaded Silicone Rubber Intrauterine Stent System	After abortion, an estradiol-loaded silicone rubber intrauterine stent system was placed for 21+2 days, and oral anti-infective medication was administered for 3 days postoperatively.
DEVICE	No-Drug-Loaded Silicone Rubber Intrauterine Stent System	After abortion, a no-drug-loaded silicone rubber intrauterine stent system was placed for 21+2 days, and oral anti-infective medication was administered for 3 days postoperatively.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-30
• Completion: 2026-08-31
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: China