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

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.

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

Consenting subjects will be screened for eligibility and will have a baseline evaluation, including medical and gynecological history, and characterization of their menstrual cycle.

Eligible subjects will be tentatively scheduled for Juveena HS treatment, aiming for device placement no later than 3 days into the anticipated HMB component of their menstrual cycle. Subjects will be provided access to and instructions for populating a diary based on the Mansfield-Voda-Jorgensen (MVJ) menstrual bleeding scale, to be started on day 1 of the index menstrual period. On treatment day, eligibility will be confirmed (including confirmation of HMB and a negative urine pregnancy test) and an MVJ score documented pre- and post-treatment. Phone visits will be conducted post-treatment Days 1, 14 and 56. Clinic visits will be conducted post-treatment on Day 7 and Day 28.

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.