RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-01

Study Completion:2025-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06634719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Ian Feldberg

CONTACT

1-978-760-1742

ian.feldberg@rejoni.com

Jonathan Bissett

CONTACT

1-617-877-7599

jonathan.bissett@rejoni.com

Study Locations (Sites)

Arizona Gynecology Consultants

Phoenix, Arizona, 85006

United States

Collaborators and Investigators

Sponsor: Rejoni Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01

Study Completion Date2025-06-01

Study Record Updates

Study Start Date2025-02-01

Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

Heavy Menstrual Bleeding