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 (4) 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
Arkansas
Applied Research Center of Arkansas
RECRUITING
Little Rock
Arizona
Arizona Gynecology Consultants
WITHDRAWN
Phoenix
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