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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Premenopausal
Be older than 18 years old
Must not have
Postmenopausal
Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Summary
This trial is testing if Juveena hydrogel can safely and effectively reduce scar tissue formation in women who have had certain types of uterine surgeries. The gel is applied inside the uterus to prevent the walls from sticking together during healing.
Who is the study for?
This trial is for premenopausal women at high risk of developing intrauterine adhesions, such as those needing hysteroscopic procedures like adhesiolysis or myomectomy. Participants must agree to avoid hormonal contraception and IUDs, not be pregnant or breastfeeding, have no history of certain cancers or infections, and commit to study requirements.
What is being tested?
The study tests if the Juveena Hydrogel System can prevent scarring inside the uterus after a procedure that could cause these adhesions. Women will either receive this new hydrogel treatment along with their surgery (TCGP + Juveena) or just the surgery alone to compare outcomes.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions to ingredients in the hydrogel (like FD&C No.1 dye or polyethylene glycol), infection due to introducing substances into the uterus, and general discomfort from the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not gone through menopause.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have gone through menopause.
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I have had endometrial cancer or a precancerous condition of the uterus.
Select...
I have had surgery inside my uterus within the last 2 months.
Select...
I do not have any current infections, including sexually transmitted or urinary tract infections.
Select...
I have not taken any corticosteroids in the last week.
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I am currently using a long-acting hormone treatment.
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Doctors couldn't access my uterine cavity during a check-up.
Select...
I have a known clotting defect or bleeding disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Freedom from intrauterine adhesions (IUA)
Secondary study objectives
Freedom of IUA with superiority margin of 5% over control at IUA
Severity of IUA
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transcervical Gynecological Procedure + Juveena HydrogelExperimental Treatment1 Intervention
Transcervical Gynecological Procedure + Juveena Hydrogel
Group II: Transcervical Gynecological Procedure alone (standard of care)Active Control1 Intervention
Transcervical Gynecological Procedure alone (standard of care)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Asherman's Syndrome treatments focus on preventing the formation of intrauterine adhesions and promoting the healing of the uterine lining. Common treatments include physical barriers like intrauterine devices (IUDs) or balloons, hormonal treatments, and barrier gels such as the Juveena hydrogel.
These physical barriers keep the uterine walls apart during healing, preventing new adhesions from forming. This is crucial for patients as it helps restore normal uterine function, improving fertility outcomes and reducing symptoms.
Management, Prevention, and Sequelae of Adhesions in Women Undergoing Laparoscopic Gynecologic Surgery: A Systematic Review.Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility.
Management, Prevention, and Sequelae of Adhesions in Women Undergoing Laparoscopic Gynecologic Surgery: A Systematic Review.Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility.
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Who is running the clinical trial?
Rejoni Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Ian FeldbergStudy DirectorRejoni Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery inside my uterus within the last 2 months.I have not taken any corticosteroids in the last week.I agree not to use hormonal birth control or IUDs until after Week 8 of the study.I have had endometrial cancer or a precancerous condition of the uterus.I have a known clotting defect or bleeding disorder.I do not have any current infections, including sexually transmitted or urinary tract infections.I am a candidate for a procedure to remove uterine scar tissue or fibroids confirmed by imaging.You cannot participate or plan to participate in another research study while in this one.I am scheduled for procedures inside my uterus, like removing fibroids, after joining the study.You are allergic to FD&C No.1 dye or polyethylene glycol (PEG).I have gone through menopause.I have not gone through menopause.I am willing to have a small lymph node biopsy at Week 8.You have a health or mental condition that could put you at risk during the study or make it difficult for you to follow the study instructions.Doctors couldn't access my uterine cavity during a check-up.I am currently using a long-acting hormone treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Transcervical Gynecological Procedure alone (standard of care)
- Group 2: Transcervical Gynecological Procedure + Juveena Hydrogel
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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