Juveena Hydrogel System for Menorrhagia

Recruiting at 1 trial location

Overseen By Jonathan Bissett

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Rejoni Inc.

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, IUD use, Dysmenorrhea, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System for temporary control of heavy menstrual bleeding (HMB) in women with a history of chronic ovulatory HMB.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot start any new hormone treatments or other medical interventions for bleeding unless it's necessary for your health.

What data supports the effectiveness of the Juveena Hydrogel System treatment for menorrhagia?

Research on similar hydrogel systems shows they can effectively deliver drugs in the vaginal area, which might help in treating conditions like menorrhagia (heavy menstrual bleeding). For example, hydrogels have been used to deliver hormones and other substances effectively in the vaginal area, suggesting that the Juveena Hydrogel System could also be effective in managing menorrhagia. ^{1 2 3 4 5}

Is the Juveena Hydrogel System safe for human use?

Research on similar hydrogel systems for vaginal use in animals and humans suggests they are generally safe, with no significant adverse effects reported. For example, a study on a hydrogel system for vaginal drug delivery in rabbits found it to be safe, and a trial of a similar gel in humans showed no systemic toxicity or significant genital irritation. ^{4 6 7 8 9}

How does the Juveena Hydrogel System treatment for menorrhagia differ from other treatments?

The Juveena Hydrogel System is unique because it uses a thermosensitive hydrogel that can be administered vaginally, allowing for prolonged retention and potentially reducing the frequency of administration compared to traditional treatments. This system leverages bioadhesive properties to stay in place longer, which may enhance its effectiveness for treating menorrhagia. ^{1 4 7 10 11}

Eligibility Criteria

This trial is for women aged 18-45 with chronic heavy menstrual bleeding (HMB) that affects their quality of life. Participants must have a history of HMB, not be on hormone therapy or willing to stop it, and use effective birth control. They should also commit to follow-up exams and sign consent forms.

Inclusion Criteria

I am a woman aged 18-45 seeking treatment for heavy menstrual bleeding.

I am using effective birth control or practicing abstinence.

I can attend all follow-up exams.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Evaluation

Baseline evaluation including medical and gynecological history and menstrual cycle characterization

1 week

1 visit (in-person)

Treatment

One-time instillation of the Juveena Hydrogel into the uterine cavity, with eligibility confirmed on treatment day

1 day

1 visit (in-person)

Post-treatment Monitoring

Participants monitored for safety and effectiveness, with phone visits on Days 1, 14, and 56, and clinic visits on Days 7 and 28

8 weeks

2 visits (in-person), 3 visits (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Juveena Hydrogel System

Trial Overview The Juveena Hydrogel System is being tested for its safety and ability to temporarily control heavy menstrual bleeding in women. This single-arm study involves multiple centers where participants will receive the hydrogel system intervention.

Participant Groups

Group I: Juveena Hydrogel System Experimental Treatment 1 Intervention

One time instillation of the Juveena Hydrogel into the uterine cavity.

Who Is Running the Clinical Trial?

Rejoni Inc.

Lead Sponsor

Trials

3

Recruited

190+

Findings from Research

Hydrogel systems are being developed for the effective intravaginal delivery of antibacterial, antifungal, and anti-Trichomonas drugs, enhancing drug solubility and bioavailability through innovative strategies like bigel systems and the use of nanoparticles.

These hydrogels are designed to improve administration and distribution within the vaginal mucosa, utilizing thermoresponsive properties to gel under vaginal conditions, which may enhance treatment efficacy for gynecological infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial Polymer-Based Hydrogels for the Intravaginal Therapies-Engineering Considerations. Gosecka, M., Gosecki, M.[2021]

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]

Using a hyaluronic acid-based hydrogel (HABH) during ovarian autotransplantation in a rat model significantly increased the number of surviving follicles and reduced follicle loss due to ischemia, indicating its potential efficacy in preserving ovarian function.

The study found that encapsulating ovarian tissue with HABH alone improved follicular survival and promoted angiogenesis, while also lowering FSH hormone levels, suggesting a beneficial effect on ovarian health post-transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic acid-based hydrogel scaffold without angiogenic growth factors enhances ovarian tissue function after autotransplantation in rats. Tavana, S., Azarnia, M., Valojerdi, MR., et al.[2018]

The vaginal route for drug delivery offers significant advantages, such as avoiding the first-pass effect and having a large surface area for absorption, making it suitable for both local and systemic treatments.

Bioadhesive drug delivery systems, using mucoadhesive polymers, can enhance the retention of medications in the vaginal cavity, potentially improving therapeutic outcomes for local conditions and contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mucoadhesive vaginal drug delivery systems. Acartürk, F.[2019]

In a study of 42 postmenopausal women, both vaginal tablets of estradiol and hyaluronic acid significantly relieved symptoms of atrophic vaginitis, but estradiol was more effective in symptom relief and improving vaginal maturation.

While both treatments decreased vaginal pH and epithelial atrophy, the improvements were notably greater with estradiol, suggesting it may be the preferred option for more effective treatment, although hyaluronic acid remains a viable alternative for those avoiding estrogen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of hyaluronic acid vaginal tablets with estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Ekin, M., Yaşar, L., Savan, K., et al.[2013]

A survey of 1866 women in Western Kenya revealed that a high percentage of users experienced menstrual bleeding problems with injectables (69%-79%) and implants (55%-60%), which negatively impacted their satisfaction and likelihood of future use.

Heavy menstrual bleeding was particularly detrimental to method evaluations among past users, highlighting the need for better counseling and information on contraceptive side effects to improve user satisfaction and reduce discontinuation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which contraceptive side effects matter most? Evidence from current and past users of injectables and implants in Western Kenya. Odwe, G., Obare, F., Machiyama, K., et al.[2022]

The study found that a thermosensitive hydrogel system for vaginal drug delivery, enhanced with carrageenan and carbopol, significantly prolonged the retention time in the mouse vagina after administration.

The optimal formulation of this hydrogel was demonstrated to be safe for vaginal use in rabbits, indicating its potential for effective and safe drug delivery in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo evaluation of an in-situ hydrogel system for vaginal administration. Li, C., Han, C., Zhu, Y., et al.[2016]

The study involving 73 sexually active women assessed the safety and acceptability of a 0.125% dextrin sulfate gel, finding no systemic toxicity or genital damage associated with its use.

While some women reported light intermenstrual bleeding during the trial, it was generally mild and resolved quickly, indicating that the gel is well-tolerated overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dextrin sulfate as a vaginal microbicide: randomized, double-blind, placebo-controlled trial including healthy female volunteers and their male partners. Low-Beer, N., Gabe, R., McCormack, S., et al.[2021]

In a 4-week randomized trial involving 109 sexually active women, dextrin sulphate (DS) gel demonstrated a satisfactory safety profile, with no significant differences in adverse events compared to placebo and observation groups.

Over 95% of participants found the DS gel acceptable, indicating it could be a viable option for use without major safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled safety and acceptability trial of dextrin sulphate vaginal microbicide gel in sexually active women in Uganda. Bakobaki, JM., Lacey, CJ., Bukenya, MI., et al.[2019]

Loading human placenta-derived mesenchymal stem cells (HP-MSCs) with hyaluronic acid hydrogel significantly improved their retention in the mouse uterus and enhanced endometrial recovery, leading to increased endometrial thickness and improved embryo implantation rates.

The therapeutic effects of HP-MSCs-HA were linked to their ability to promote cell proliferation and angiogenesis through specific signaling pathways, indicating a promising approach for treating thin endometrium and related infertility issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic regenerative therapy of thin endometrium by human placenta-derived mesenchymal stem cells encapsulated within hyaluronic acid hydrogels. Lin, Y., Dong, S., Ye, X., et al.[2022]

Kappa-carrageenan hydrogels can be engineered to swell significantly in simulated body fluid, making them potential candidates for occluding the vasa deferentia, which is important for male contraception.

The study found that pre-drying the hydrogels and adjusting potassium concentrations enhances their swelling ability, with the fastest swelling observed in ethanol-exchanged and pre-dried gels, indicating a method to optimize their performance for medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swelling of kappa carrageenan hydrogels in simulated body fluid for hypothetical vessel occlusion applications. Wurm, F., Lerchster, N., Pinggera, GM., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Antimicrobial Polymer-Based Hydrogels for the Intravaginal Therapies-Engineering Considerations. [2021]

2. New Zealand 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. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Hyaluronic acid-based hydrogel scaffold without angiogenic growth factors enhances ovarian tissue function after autotransplantation in rats. [2018]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Mucoadhesive vaginal drug delivery systems. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

The comparison of hyaluronic acid vaginal tablets with estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Which contraceptive side effects matter most? Evidence from current and past users of injectables and implants in Western Kenya. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

In vivo evaluation of an in-situ hydrogel system for vaginal administration. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Dextrin sulfate as a vaginal microbicide: randomized, double-blind, placebo-controlled trial including healthy female volunteers and their male partners. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A randomized controlled safety and acceptability trial of dextrin sulphate vaginal microbicide gel in sexually active women in Uganda. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Synergistic regenerative therapy of thin endometrium by human placenta-derived mesenchymal stem cells encapsulated within hyaluronic acid hydrogels. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Swelling of kappa carrageenan hydrogels in simulated body fluid for hypothetical vessel occlusion applications. [2022]