Juveena Hydrogel System for Asherman's Syndrome

No longer recruiting at 16 trial locations

Overseen By Jonathan Bissett

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Rejoni Inc.

Must not be taking: Systemic corticosteroids, Long-acting hormones

Disqualifiers: Postmenopausal, Endometrial cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Juveena hydrogel, used after a standard gynecological procedure, can safely and effectively reduce the formation of uterine scar tissue, known as intrauterine adhesions. It compares the results of the procedure alone to those with the added hydrogel. Premenopausal women with a confirmed need for hysteroscopic procedures related to moderate to severe uterine issues may be suitable candidates. Participants must follow specific guidelines, such as avoiding sexual intercourse or using barrier contraception for a period after the procedure. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment nearing widespread availability.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use systemic corticosteroids within 1 week of the study procedure or have long-acting injectable hormones that would still be active at the time of the procedure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use systemic corticosteroids within 1 week of the study procedure or have long-acting hormone treatments active at the time of the procedure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Juveena Hydrogel System is being tested for its ability to safely reduce scar tissue inside the uterus in women who have undergone uterine surgeries. Earlier studies found that patients generally tolerate the hydrogel well. No major reports of serious side effects have emerged, suggesting it is safe for humans. As this treatment advances in testing, researchers have collected substantial evidence about its safety. This stage typically indicates that the treatment is safe enough for testing in larger groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Asherman's Syndrome?

Researchers are excited about the Juveena Hydrogel System for Asherman's Syndrome because it offers a new approach to preventing scar tissue formation after surgery. Unlike the standard treatment, which mainly involves a transcervical gynecological procedure, Juveena Hydrogel serves as a physical barrier that can be applied directly to the uterine lining. This innovation helps in reducing adhesion formation, potentially preserving fertility and improving recovery outcomes. By integrating this hydrogel with the traditional procedure, there is hope for more effective long-term results for patients suffering from this condition.

What evidence suggests that the Juveena Hydrogel System is effective for reducing intrauterine adhesions in Asherman's Syndrome?

Research has shown that the Juveena Hydrogel System might help reduce scar tissue in the uterus after certain surgeries. In this trial, participants will either undergo a transcervical gynecological procedure alone or receive the procedure combined with Juveena Hydrogel. Past patients who used Juveena Hydrogel experienced less severe scar tissue, known as intrauterine adhesions. These adhesions often relate to Asherman's syndrome, which can cause infertility, irregular periods, and miscarriages. The hydrogel acts as a temporary barrier, preventing scar tissue from forming or returning. Early studies suggest Juveena Hydrogel could effectively manage these issues. ^{1 2 3 5 6}

Who Is on the Research Team?

Ian Feldberg

Principal Investigator

Rejoni Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.

I agree not to use hormonal birth control or IUDs until after Week 8 of the study.

Subject has signed the IRB/EC approved informed consent

Exclusion Criteria

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

Pregnant (positive pregnancy test) or lactating.

I have not taken any corticosteroids in the last week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcervical Gynecological Procedures with or without Juveena Hydrogel

8 weeks

Includes a second look hysteroscopy at Week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Juveena Hydrogel System

Trial Overview 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.

How Is the Trial Designed?

Group I: Transcervical Gynecological Procedure + Juveena Hydrogel Experimental Treatment 1 Intervention

Transcervical Gynecological Procedure + Juveena Hydrogel

Group II: Transcervical Gynecological Procedure alone (standard of care) Active Control 1 Intervention

Transcervical Gynecological Procedure alone (standard of care)

Who Is Running the Clinical Trial?

Rejoni Inc.

Lead Sponsor

Trials

3

Recruited

190+

Published Research Related to This Trial

Mesenchymal stem cell-secretome (MSC-Sec) offers a safer alternative to live stem cell therapies for treating endometrial injuries and preventing Asherman's syndrome, as it has a superior safety profile and can be stored without losing effectiveness.

The study demonstrates that a new treatment using crosslinked hyaluronic acid gel loaded with MSC-Sec can effectively repair endometrial injuries in rats and promote viable pregnancies, indicating its potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic Acid Hydrogel Integrated with Mesenchymal Stem Cell-Secretome to Treat Endometrial Injury in a Rat Model of Asherman's Syndrome. Liu, F., Hu, S., Yang, H., et al.[2023]

A user-testing study involving 13 participants, including women with experience of vaginal mesh implants, found that a newly developed patient resource on complications was generally clear and helpful, enhancing usability with features like easy-to-read fonts and simple language.

The study emphasized the importance of health professionals in guiding patients through the resource, which could improve understanding and interpretation of the information provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User testing a patient information resource about potential complications of vaginally inserted synthetic mesh. Angelova, N., Taylor, L., McKee, L., et al.[2021]

In a study of 201 women, both pubovaginal sling (PVS) and synthetic midurethral sling (MUS) procedures showed similar efficacy in treating urinary incontinence, with cure rates of 75.8% for PVS and 80.9% for MUS after a median follow-up of 13.8 months.

Complication rates and voiding difficulties were comparable between the two groups, suggesting that PVS can be a safe alternative for patients concerned about mesh implantation associated with MUS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary comparison between retropubic midurethral sling and autologous pubovaginal sling for stress urinary incontinence after the FDA advisory notification. Mock, S., Angelle, J., Reynolds, WS., et al.[2015]

Asherman's syndrome, a condition caused by intrauterine adhesions, often requires repeated surgeries due to high rates of adhesion recurrence, highlighting the importance of secondary prevention strategies.

Current secondary prevention methods, including second-look hysteroscopy, hormonal treatments, and barrier techniques, show varying efficacy, but combining barriers with hormonal support for endometrial regeneration appears to be the most promising approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of de novo adhesion formation in patients with Asherman's syndrome. BarboraBoudová, Barbora., Lisá, Zdeňka., Richtárová, Adéla., et al.[2021]

The study evaluated 20 patients with Asherman syndrome treated in an outpatient hysteroscopy clinic, showing that 84% had no or mild adhesions after treatment, indicating a high success rate for outpatient management.

All patients reported normal menstrual cycles post-treatment, and 6 patients achieved spontaneous pregnancies, with 5 resulting in term deliveries, demonstrating the efficacy of outpatient hysteroscopic adhesiolysis without the need for general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Asherman's syndrome in an outpatient hysteroscopy setting. Bougie, O., Lortie, K., Shenassa, H., et al.[2022]

In a study involving 272 patients with moderate-to-severe intrauterine adhesions, the use of auto-cross-linked hyaluronic acid gel after hysteroscopic adhesiolysis did not significantly reduce the recurrence of intrauterine adhesions compared to standard care alone.

There were no notable differences in the improvement of menstrual patterns or AFS scores between the treatment group and the control group, indicating that the gel did not provide additional benefits in recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auto-Cross-Linked Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions after Hysteroscopic Adhesiolysis: A Randomized Controlled Trial. Zhou, Q., Shi, X., Saravelos, S., et al.[2021]

In a study of 107 women with Asherman's syndrome, both the intrauterine balloon and intrauterine contraceptive device (IUD) significantly reduced adhesion reformation after hysteroscopic adhesiolysis compared to hyaluronic acid gel and control groups.

The intrauterine balloon was found to be more effective than the IUD in preventing adhesion reformation, highlighting the superiority of mechanical methods over the gel treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Lin, X., Wei, M., Li, TC., et al.[2022]

A decellularized endometrial hydrogel (EndoECM) was shown to promote significant endometrial regeneration and fertility restoration in a mouse model, particularly when supplemented with growth factors, leading to increased gland numbers, cell proliferation, and new blood vessel formation.

The study suggests that EndoECM hydrogels could be a promising treatment for endometrial conditions like Asherman's syndrome and endometrial atrophy, which currently lack effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioengineered endometrial hydrogels with growth factors promote tissue regeneration and restore fertility in murine models. López-Martínez, S., Rodríguez-Eguren, A., de Miguel-Gómez, L., et al.[2021]

In a study of 216 women using the levonorgestrel-releasing intrauterine system (LNG-IUS) for heavy menstrual bleeding, 39.5% opted for a second device after the initial 5-year period, indicating good long-term acceptability.

The main reason for early removal of the LNG-IUS was menopause, with 47.1% of early removals attributed to this, suggesting that the device is effective and well-tolerated until menopause occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of the levonorgestrel intrauterine system in the long-term treatment of heavy menstrual bleeding: how many women choose to use a second device? Lete, I., del Carme Cuesta, M., Marín, JM., et al.[2013]

A review of 42 medical device reports on vaginal energy-based devices revealed that most patient complaints, including vaginal pain and urinary symptoms, were not severe, with serious adverse events being rare (only 3.5% reported third-degree burns).

The majority of complaints were reported after the FDA's July 30, 2018 warning, suggesting that increased awareness and potential litigation may have influenced reporting rates, highlighting the need for further research on the safety and efficacy of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Wallace, SL., Sokol, ER., Enemchukwu, EA.[2021]

Hydrogels are emerging as a promising treatment for intrauterine adhesions (IUAs) by encapsulating therapeutic agents like estrogen and cytokines, which can help in the repair of the endometrial lining.

These hydrogels not only deliver medication effectively but also serve as a temporary barrier that degrades naturally in the body, minimizing the risk of infection associated with additional surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel, a novel therapeutic and delivery strategy, in the treatment of intrauterine adhesions. Lv, H., Wu, B., Song, J., et al.[2022]

The E2-HP hydrogel, which encapsulates 17β-estradiol, demonstrated a sustained release and significantly improved endometrium regeneration in a rat model of intrauterine adhesions (IUA), indicating its potential as an effective treatment.

The therapeutic effects of the E2-HP hydrogel were linked to the suppression of endoplasmic reticulum (ER) stress signals, suggesting that targeting ER stress could be a promising strategy for treating IUA in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional structure micelles of heparin-poloxamer improve the therapeutic effect of 17β-estradiol on endometrial regeneration for intrauterine adhesions in a rat model. Zhang, SS., Xia, WT., Xu, J., et al.[2018]

The media coverage in France in 2017 significantly increased the reporting of adverse events (AEs) related to the Mirena intrauterine device, with reports rising from 510 (15.8%) before the media peak to 2714 (84.2%) after.

After the media coverage, reports predominantly came from patients (98.6%) rather than health professionals, and highlighted new concerns such as anxio-depressive disorders and sexual disorders, indicating a shift in the perception of Mirena's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage. Langlade, C., Gouverneur, A., Bosco-Lévy, P., et al.[2021]

Intrauterine infusion of autologous platelet-rich plasma (PRP) was well tolerated by patients with moderate-severe Asherman syndrome (AS), showing no adverse effects during the procedure.

However, the study found no significant improvements in endometrial thickness or pregnancy rates when comparing PRP infusion to saline control, indicating that while PRP is a safe option, its efficacy in enhancing fertility outcomes in AS patients remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma treatment for moderate-severe Asherman syndrome: the first experience. Aghajanova, L., Sundaram, V., Kao, CN., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-f88cd

Juveena Hydrogel System for Asherman's Syndrome 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.

2. txfertility.com txfertility.com/clinical-study/rejoni-juveena-hydrogel-study/

Rejoni-Juveena Hydrogel Study - Fertility Studies in Texas These adhesions, often referred to as Asherman's syndrome, can lead to infertility, menstrual irregularities, and recurrent miscarriages, significantly ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05394662

Safety and Effectiveness of Juveena™ Hydrogel System ... This is a prospective, multicenter, randomized controlled subject and evaluator-blinded pivotal study to investigate the safety and effectiveness of the Juveena ...

4. pramandllc.com pramandllc.com/f/rejoni-completes-patient-enrollment-for-pivotal-clinical-study

Rejoni completes patient enrollment for pivotal clinical study The Juveena Hydrogel System, is an investigational device intended for use as a temporary implant to prevent the formation or reformation of intrauterine ...

5. mpo-mag.com mpo-mag.com/breaking-news/enrollment-ends-for-study-of-intrauterine-adhesion-treatment-device/

Enrollment Ends for Study of Intrauterine Adhesion ... Rejoni completes patient enrollment in its Juveena Hydrogel pivotal study. The hydrogel aims to prevent intrauterine adhesions.

6. malacards.org malacards.org/card/asherman_syndrome

Asherman Syndrome Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical ... Hormonal support in women with Asherman syndrome does not lead to better outcomes ...