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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Female aged 18 to 45 years inclusive seeking treatment for HMB

• 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).

• Historical menstrual pattern with at least 3 days (72 hours) of HMB as determined by retrospective MVJ Bleeding scale score of ≥5for prior cycle.

• Menses frequency (24-38 days) based on subjectparticipant reporting.

• Menses regularity - shortest to longest period is ≤8 days based on subjectparticipant reporting.

• 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).

• HMB refractory to hormone therapy, hormone therapy contraindicated, or subjectparticipant does not wish to continue hormone therapy.

• The subjectparticipant is literate and clearly demonstrates an understanding of how to complete the MVJ Scale and other patient-reported outcomes.

• Able and willing to comply with the study protocol and agrees to the following during participation in the study:

∙ 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)

‣ 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)

‣ 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

⁃ Demonstrates understanding of the study and signs the written informed consent form.

Locations
United States
Arizona
Arizona Gynecology Consultants
RECRUITING
Pheonix
New Jersey
Rubino OB/GYN (Axia Women's Health)
RECRUITING
West Orange
Ohio
Seven Hills Clinical Research Group, LLC
RECRUITING
Cincinnati
Contact Information
Primary
Ian Feldberg
ian.feldberg@rejoni.com
1-978-760-1742
Backup
Jonathan Bissett
jonathan.bissett@rejoni.com
1-617-877-7599
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 7
Treatments
Experimental: Juveena Hydrogel System
One time instillation of the Juveena Hydrogel into the uterine cavity.
Related Therapeutic Areas
Sponsors
Leads: Rejoni Inc.

This content was sourced from clinicaltrials.gov