Actively Recruiting
A Prospective Multicenter Safety and Feasibility Study of the Juveena Hydrogel System for Temporary Control of Chronic Ovulatory Heavy Menstrual Bleeding (HMB)
Led by Rejoni Inc. · Updated on 2026-04-27
7
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of the Juveena Hydrogel System for temporary control of heavy menstrual bleeding (HMB) in women who have a history of chronic ovulatory HMB. This prospective, multicenter, single-arm interventional study focuses on women experiencing repeated heavy menstrual bleeding that affects their quality of life and who may have limited treatment options due to hormone therapy issues. Participants will receive a one-time instillation of the Juveena Hydrogel System device, which is placed into the uterine cavity as a liquid and quickly forms a gel to help control bleeding. The device is to be inserted no later than three days into the expected heavy bleeding phase of the menstrual cycle. Following treatment, participants will use an electronic diary to record their bleeding severity based on a standardized scale, with scheduled follow-up visits and phone calls over a 56-day period to monitor safety and effectiveness. During the study, participants will undergo initial screening, including medical and gynecological history assessments and confirmation of heavy bleeding and pregnancy status. Researchers will evaluate menstrual bleeding scores before and after treatment, and conduct clinic visits on Days 7 and 28 post-treatment, alongside phone check-ins on Days 1, 14, and 56. The main measurement is the primary effectiveness endpoint assessed within seven days after treatment. Participants are expected to comply with study procedures, including using non-hormonal birth control and completing electronic diaries throughout the study period, which lasts approximately two months.
CONDITIONS
Brief 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 inclusive seeking treatment for heavy menstrual bleeding
- Recent history within last 3 months of repeated heavy menstrual bleeding periods affecting quality of life
- Historical menstrual pattern with at least 3 days of heavy bleeding as measured by bleeding scale
- Menstrual cycle frequency between 24 and 38 days
- Menstrual cycle regularity with shortest to longest period difference of 8 days or less
- Currently experiencing heavy to very heavy menstrual bleeding with a bleeding scale score of 5 or higher
- Heavy menstrual bleeding not responding to hormone therapy, hormone therapy contraindicated, or participant declines hormone therapy
- Ability to read and understand how to complete bleeding and patient-reported outcome scales
- Willingness to comply with study protocol including non-hormonal birth control, no hormone use during study, and completion of electronic diaries
- Signed informed consent and understanding of the study
You will not qualify if you...
- Pregnancy or breastfeeding within the past 3 months or planning pregnancy during the study
- Current or recent intrauterine device use within last 2 menstrual cycles
- Severe menstrual pain preventing study participation
- Hemoglobin less than 8 g/dL at screening
- Suspected or known uterine or cervical malignancy or precancerous condition
- Active pelvic infection or sexually transmitted disease
- Presence of bacteremia, sepsis, or other systemic infection
- Current use of anticoagulant medications
- Allergy to PEG or FD&C Blue#1 dye
- Planning surgery or other treatments for heavy menstrual bleeding during study period
- Presence of certain uterine abnormalities exceeding size limits
- Irregular menstrual cycles with variability over 7 days
- Bleeding disorders or coagulopathies
- Participation in other investigational drug or device studies
- Any health, mental, or social condition that increases risk or affects ability to complete study requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Device placement no later than 3 days into the anticipated heavy menstrual bleeding component of their menstrual cycle
Participants receive a one-time placement of the Juveena Hydrogel System device into the uterine cavity to temporarily control heavy menstrual bleeding.
1 treatment visit (in-person)
Duration - Up to 56 days post-treatment
Participants complete post-treatment monitoring including phone and clinic visits to assess safety and effectiveness of the device.
Phone visits on Days 1, 14, and 56; Clinic visits on Days 7 and 28 post-treatment
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
J
Jonathan Bissett
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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