Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions

Completed · Phase 3

Conditions studied: Intrauterine Adhesion

In brief

This study is to determine whether intrauterine instillation of Juveena hydrogel following adhesiogenic hysteroscopic procedures (TCGP + Juveena) can safely and effectively reduce the incidence and severity of intrauterine adhesions (IUA) compared to TCGP alone.

Key facts

Study ID

NCT05394662

Run by

Rejoni Inc.

People needed

150

Starts

2022-08-11

Expected to finish

2025-04-23

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Premenopausal
• Candidate for one of the following hysteroscopic procedures:
• Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically
• Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease
• Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
• Subject is willing to undergo an SLH at the Week 8 visit.
• Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit.
• Subject has signed the IRB/EC approved informed consent

You may not qualify if…

• Postmenopausal
• IUD present at time of TCGP (unless removed before or during procedure)
• Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia).
• Planned intrauterine interventions post-TCGP through the Week 8 visit.
• Recent intrauterine surgery within 6 weeks before the planned study procedure.
• Pregnant (positive pregnancy test) or lactating.
• Pregnancy within the last 6 weeks prior to the planned study procedure for a trimester loss (≤13 weeks gestation) within 3 months of planned study procedure for all other pregnancies.
• Active sexually transmitted infection (i.e., positive testing for gonorrhea/chlamydia), or genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or other active and/or systemic infection.
• Use of systemic corticosteroids within 1 week of study procedure.
• Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP.
• Known allergy to FD\&C No.1 dye or polyethylene glycol (PEG).
• Known clotting defects or bleeding disorders.
• Any other general health or mental condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
• Participating or considering participation in a clinical trial of another investigational drug or device during this study.

Where it is running

• Arizona Gynecology Consultants — Phoenix, Arizona, United States
• UCSF Center for Reproductive Health — San Francisco, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Dr. Charles Miller and Associates — Park Ridge, Illinois, United States
• Cypress Medical Research Center — Wichita, Kansas, United States
• Newton Wellesley Hospital — Newton, Massachusetts, United States
• Boston IVF — Waltham, Massachusetts, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Duke Universtiy Health System — Morrisville, North Carolina, United States
• University Hospitals Landerbrook — Mayfield Heights, Ohio, United States
• Prisma Health, Greensville Memorial Hospital — Greenville, South Carolina, United States
• The University of Texas at Austin Dept of Womens' Health — Austin, Texas, United States
• Texas Fertility Center — Austin, Texas, United States
• Aspire Houston Fertility Institute — Houston, Texas, United States
• Generations Fertility Care — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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