Feasibility of Juveena Hydrogel for Heavy Menstrual Bleeding

A Prospective Multicenter Safety and Feasibility Study of the Juveena Hydrogel System for Use for Temporary Control of Chronic Ovulatory Heavy Menstrual Bleeding (HMB)

This study is testing a new hydrogel treatment to see if it can help women with heavy menstrual bleeding feel better and manage their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Rejoni Inc. (Industry-sponsored)
• Locations: 4 sites (Phoenix, Arizona and 3 other locations)
• Trial ID: NCT06634719 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, single-arm interventional feasibility study evaluates the safety and feasibility of the Juveena Hydrogel System for controlling heavy menstrual bleeding (HMB) in women with a history of chronic ovulatory HMB. Eligible participants will undergo a baseline evaluation and have the device placed during their menstrual cycle. They will track their bleeding using a diary based on the Mansfield-Voda-Jorgensen scale, with follow-up assessments conducted through phone and clinic visits. The study aims to determine the effectiveness of the hydrogel system in managing HMB.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 45 with a recent history of heavy menstrual bleeding that affects their quality of life.

Not a fit: Patients whose heavy menstrual bleeding is adequately managed by hormone therapy or who are not seeking alternative treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for women suffering from heavy menstrual bleeding.

How similar studies have performed: While this approach is novel, similar studies have shown promise in managing heavy menstrual bleeding with innovative devices.

Eligibility criteria

Inclusion Criteria:

1. Female aged 18 to 45 years inclusive seeking treatment for HMB
2. Recent history (within the last 3 months) of repeat periods of HMB that adversely affects quality of life (Modified SAMANTA score ≥4 and comprises at least three consecutive days of HMB, see Appendix 2).(23).
3. Historical menstrual pattern with at least 3 days (72 hours) of HMB as determined by retrospective MVJ Bleeding scale score of ≥5for prior cycle.
4. Menses frequency (24-38 days) based on subjectparticipant reporting.
5. Menses regularity - shortest to longest period is ≤8 days based on subjectparticipant reporting.
6. Actively experiencing heavy to very heavy menstrual bleeding (HMB) at the time of the Juveena HS treatment, i.e., MVJ score of ≥5 (treatment must be performed no later than Day 3 of the index period).
7. HMB refractory to hormone therapy, hormone therapy contraindicated, or subjectparticipant does not wish to continue hormone therapy.
8. The subjectparticipant is literate and clearly demonstrates an understanding of how to complete the MVJ Scale and other patient-reported outcomes.
9. Able and willing to comply with the study protocol and agrees to the following during participation in the study:

   1. Use an effective non-hormonal method of birth control until the Day 28 visit. Acceptable methods of birth control for use in this study are abstinence and barrier contraceptives (e.g. condom)
   2. No initiation or continuation of hormone use (including contraception) or any other medical intervention for bleeding until after the Day 28 visit (unless clinically necessary, e.g., the subjectparticipant becomes hemodynamically unstable)
   3. Attends the follow-up examexams and completion of electronic diaries via a secured internet website (subject must have internet accesscompletes the MVJ scale and will be trained on how to use the eDiary)other patient-reported outcomes per the schedule of events
10. Demonstrates understanding of the study and signs the written informed consent form.

Exclusion Criteria:

1. Pregnancy and/or breastfeeding within the past 3 months or planning to become pregnant during the duration of this study.
2. Currently using an intrauterine device (IUD) or has undergone removal within the last 2 menstrual cycles.
3. Dysmenorrhea of a severity that, in the opinion of the investigator, precludes participation in the study.
4. Hemoglobin of \< 8 g/dL at the time of screening.
5. Suspected or known malignancy or premalignant condition of the uterus including the cervix
6. Active pelvic infection.
7. Active sexually transmitted disease (STD) at the time of treatment (STD testing to be performed)
8. Presence of bacteremia, sepsis, or other active systemic infection
9. Currently on anticoagulants
10. History of allergies to PEG or FD\&C Blue#1 dye
11. Planning to undergo surgery or other treatments for HMB during the study period (i.e., 8 weeks post-hydrogel instillation).
12. AUB-L sm with a Type 0 or 1 leiomyoma \> 1 cm
13. AUB-P (Polyp) \> 2 cm in maximum dimension based on ultrasound, hysteroscopy, or MRI performed within prior 6 months.
14. AUB-O, Irregular menstrual cycles (cycle length variability \>7 days length)
15. AUB-C (coagulopathy or bleeding disorder)
16. Any patient who is currently participating or considering participation in any other research of an investigational drug or device. Does not include observational studies
17. Any general health, mental health, or social situation which, in the opinion of the investigator, could represent an increased risk for the patient or the ability of the patient to complete study requirements.

Where this trial is running

Phoenix, Arizona and 3 other locations

• Arizona Gynecology Consultants — Phoenix, Arizona, United States (Withdrawn)
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States (Recruiting)
• Rubino OB/GYN (Axia Women's Health) — West Orange, New Jersey, United States (Recruiting)
• Seven Hills Clinical Research Group, LLC — Cincinnati, Ohio, United States (Completed)

Study contacts

• Study coordinator: Ian Feldberg

Conditions Heavy Menstrual Bleeding