Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)

Launched by REJONI INC. · Oct 8, 2024

Keywords

ClinConnect Summary

The Juveena Hydrogel System Feasibility Study is a clinical trial designed to test a new treatment for women who experience heavy menstrual bleeding (HMB). The goal of this study is to evaluate how safe and effective the Juveena Hydrogel is for temporarily controlling HMB in women who have had ongoing issues with their menstrual cycles. This trial is currently recruiting women aged 18 to 45 who have had significant bleeding problems in the past three months that affect their quality of life. Participants should not be pregnant or breastfeeding and should not have any serious health conditions that could interfere with the study.

If you qualify and choose to participate, you can expect to receive the Juveena Hydrogel treatment and attend follow-up appointments to monitor your health and how well the treatment is working. It's important to note that participants will need to use effective birth control during the study and cannot start any new hormone treatments for bleeding. This study aims to provide valuable insights into a new option for managing heavy menstrual bleeding, which can greatly impact women's daily lives.

Gender

FEMALE

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).
• • 3. Historical menstrual pattern with at least 3 days (72 hours) of HMB as determined by retrospective MVJ Bleeding scale score of ≥5 for prior cycle.
• • 4. Menses frequency (24-38 days) based on subject reporting.
• • 5. Menses regularity - shortest to longest period is ≤8 days based on subject reporting.
• • 6. HMB refractory to hormone therapy, hormone therapy contraindicated, or subject does not wish to continue hormone therapy
• 7. Able and willing to comply with the study protocol and agrees to the following during participation in the study:
• • 1. Use an effective 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 of hormone use (including contraception) or any other medical intervention for bleeding (unless clinically necessary, e.g., the subject becomes hemodynamically unstable)
• • 3. Attend the follow-up exams
• • 8. Demonstrates understanding and signs the written informed consent form
• Exclusion Criteria:
• • 1. Pregnancy and/or breast feeding within the past 3 months or planning to become pregnant during the duration of this study.
• • 2. Currently using 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 based on ultrasound, hysteroscopy, or MRI performed within prior 6 months.
• • 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.