Actively Recruiting
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
Led by Rejoni Inc. · Updated on 2026-04-27
7
Participants Needed
4
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 45 years seeking treatment for heavy menstrual bleeding
- Recent history within last 3 months of repeated heavy menstrual bleeding episodes affecting quality of life
- Menstrual pattern with at least 3 days of heavy bleeding in previous cycle
- Menstrual cycle frequency between 24 and 38 days
- Menstrual regularity with shortest to longest period variation of 8 days or less
- Currently experiencing heavy to very heavy menstrual bleeding with MVJ score of 5 or higher, treated no later than day 3 of period
- Heavy menstrual bleeding not improved by hormone therapy, hormone therapy contraindicated, or patient unwilling to continue hormone therapy
- Able to read, understand, and complete the menstrual bleeding diary and patient-reported outcomes
- Willing and able to follow study protocol, including using non-hormonal birth control until day 28, avoiding hormone therapy or other bleeding treatments until after day 28 unless medically necessary, and attending follow-up visits
- Understands the study and provides written informed consent
You will not qualify if you...
- Pregnancy or breastfeeding within past 3 months or planning pregnancy during study
- Current or recent intrauterine device use within last 2 menstrual cycles
- Severe menstrual pain preventing participation
- Hemoglobin less than 8 g/dL at screening
- Suspected or known uterine or cervical cancer or precancerous condition
- Active pelvic infection or sexually transmitted disease at treatment
- Active systemic infection like bacteremia or sepsis
- Current use of blood thinners
- Allergies to PEG or FD&C Blue#1 dye
- Planned surgery or other treatments for heavy menstrual bleeding during study
- Certain fibroids larger than 1 cm or polyps larger than 2 cm
- Irregular menstrual cycles with variability over 7 days
- Known bleeding disorders or coagulopathies
- Participation in other investigational drug or device studies
- Any health, mental, or social condition that increases risk or impairs ability to complete study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Arizona Gynecology Consultants
Phoenix, Arizona, United States, 85006
Withdrawn
2
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Rubino OB/GYN (Axia Women's Health)
West Orange, New Jersey, United States, 07052
Actively Recruiting
4
Seven Hills Clinical Research Group, LLC
Cincinnati, Ohio, United States, 45255
Completed
Research Team
I
Ian Feldberg
CONTACT
J
Jonathan Bissett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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