What side effects are associated with this type of intervention?

Treatments for Asherman's Syndrome that use physical barriers, such as intrauterine devices (IUDs) or hydrogels like Juveena, are generally well-tolerated. Common side effects of IUDs include discomfort, spotting, and rarely, uterine perforation or infection. Hydrogels can occasionally cause local irritation or allergic reactions. Both methods aim to prevent adhesion reformation after surgery, but their long-term efficacy and safety profiles need further research.

What prior FDA approvals exist?

Asherman's Syndrome, characterized by intrauterine adhesions, has been treated with various methods to prevent adhesion formation. FDA-approved treatments include the use of physical barriers such as hyaluronic acid gels (e.g., Hyalobarrier) and auto-crosslinked hyaluronic acid (ACP) gel. These gels are applied intrauterinely post-surgery to reduce the incidence and severity of adhesions by creating a physical barrier that prevents tissue surfaces from sticking together during the healing process.

What other types of research exist?

Promising alternatives to Juveena hydrogel for preventing adhesion formation in Asherman's Syndrome patients include: 1) Hyaluronic acid-based gels, which have shown effectiveness in reducing intrauterine adhesions. 2) Auto-crosslinked hyaluronic acid (ACP) gel, which has demonstrated promising results in clinical trials. 3) Oxidized regenerated cellulose (Interceed), a bioresorbable barrier that has been used successfully in gynecological surgeries. 4) Fibrin sealants, which act as a physical barrier and promote healing. These alternatives offer various mechanisms to prevent adhesion formation and are supported by recent clinical evidence.

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Juveena Hydrogel System for Asherman's Syndrome

Phase 3

Recruiting

Research Sponsored by Rejoni Inc.

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

No Placebo-Only Group

Pivotal Trial

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 below

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I have not gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have gone through menopause.

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I have had endometrial cancer or a precancerous condition of the uterus.

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I have had surgery inside my uterus within the last 2 months.

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I do not have any current infections, including sexually transmitted or urinary tract infections.

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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

Awards & Highlights

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.

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)

0 / 9Eligibility criteria met

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.