Heavy Menstrual BleedingNCT06634719
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
A study testing Juveena Hydrogel System in people with Heavy Menstrual Bleeding, run by Rejoni Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Juveena Hydrogel System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2025to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- Pregnancy and/or breastfeeding within the past 3 months or planning to become pregnant during the duration of this study.
- Currently using an intrauterine device (IUD) or has undergone removal within the last 2 menstrual cycles.
- Dysmenorrhea of a severity that, in the opinion of the investigator, precludes participation in the study.
- Hemoglobin of < 8 g/dL at the time of screening.
- Suspected or known malignancy or premalignant condition of the uterus including the cervix
- Active pelvic infection.
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- Active sexually transmitted disease (STD) at the time of treatment (STD testing to be performed)
- Presence of bacteremia, sepsis, or other active systemic infection
- Currently on anticoagulants
- History of allergies to PEG or FD\&C Blue#1 dye
- Planning to undergo surgery or other treatments for HMB during the study period (i.e., 8 weeks post-hydrogel instillation).
- AUB-L sm with a Type 0 or 1 leiomyoma > 1 cm
- AUB-P (Polyp) > 2 cm in maximum dimension based on ultrasound, hysteroscopy, or MRI performed within prior 6 months.
- AUB-O, Irregular menstrual cycles (cycle length variability >7 days length)
- AUB-C (coagulopathy or bleeding disorder)
- Any patient who is currently participating or considering participation in any other research of an investigational drug or device. Does not include observational studies
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Seven Hills Clinical Research Group, LLC
Cincinnati, Ohio, 45255
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205
Rubino OB/GYN (Axia Women's Health)
West Orange, New Jersey, 07052
About this study
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)
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.
Read the detailed description
This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System (HS) for temporary control of heavy menstrual bleeding (HMB) in women with a history of chronic ovulatory HMB.
Consenting subjects will be screened for eligibility and will have a baseline evaluation, including medical and gynecological history, and characterization of their menstrual cycle.
Eligible subjects will be tentatively scheduled for Juveena HS treatment, aiming for device placement no later than 3 days into the anticipated HMB component of their menstrual cycle. Subjects will be provided access to and instructions for populating a diary based on the Mansfield-Voda-Jorgensen (MVJ) menstrual bleeding scale, to be started on day 1 of the index menstrual period. On treatment day, eligibility will be confirmed (including confirmation of HMB and a negative urine pregnancy test) and an MVJ score documented pre- and post-treatment. Phone visits will be conducted post-treatment Days 1, 14 and 56. Clinic visits will be conducted post-treatment on Day 7 and Day 28.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Juveena Hydrogel System
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juveena Hydrogel SystemDevice
The Juveena Hydrogel System is a single-use device that is instilled into the endometrial cavity as a liquid and sets up as a gel intrauterine tamponade within seconds.
| Study group | Role | What they receive |
|---|---|---|
| Juveena Hydrogel System | Experimental | One time instillation of the Juveena Hydrogel into the uterine cavity. Receives: Device: Juveena Hydrogel System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Feasibility for invoking a tamponade effect
Measured: Within 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Feb 2025
- Primary completion22 Apr 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Women with HMB
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rejoni Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634719
- Sponsor's protocol ID
- REJ-CT-0008
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06634719
- Acronym / sponsor ID
- REJ-CT-0008
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rejoni Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System (HS) for temporary control of heavy menstrual bleeding (HMB) in women with a history of chronic ovulatory HMB.
Consenting subjects will be screened for eligibility and will have a baseline evaluation, including medical and gynecological history, and characterization of their menstrual cycle.
Eligible subjects will be tentatively scheduled for Juveena HS treatment, aiming for device placement no later than 3 days into the anticipated HMB component of their menstrual cycle. Subjects will be provided access to and instructions for populating a diary based on the Mansfield-Voda-Jorgensen (MVJ) menstrual bleeding scale, to be started on day 1 of the index menstrual period. On treatment day, eligibility will be confirmed (including confirmation of HMB and a negative urine pregnancy test) and an MVJ score documented pre- and post-treatment. Phone visits will be conducted post-treatment Days 1, 14 and 56. Clinic visits will be conducted post-treatment on Day 7 and Day 28.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Women with HMB
| Arm | Type | Receives |
|---|---|---|
| Juveena Hydrogel System | Experimental | Device: Juveena Hydrogel SystemOne time instillation of the Juveena Hydrogel into the uterine cavity. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (17 listed)
- Pregnancy and/or breastfeeding within the past 3 months or planning to become pregnant during the duration of this study.
- Currently using an intrauterine device (IUD) or has undergone removal within the last 2 menstrual cycles.
- Dysmenorrhea of a severity that, in the opinion of the investigator, precludes participation in the study.
- Hemoglobin of < 8 g/dL at the time of screening.
- Suspected or known malignancy or premalignant condition of the uterus including the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juveena Hydrogel SystemThe Juveena Hydrogel System is a single-use device that is instilled into the endometrial cavity as a liquid and sets up as a gel intrauterine tamponade within seconds. | Device | Juveena Hydrogel System |
Primary outcome
Primary Effectiveness Endpoint
Time frame: Within 7 days post-treatment
Feasibility for invoking a tamponade effect
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juveena Hydrogel System in people with Heavy Menstrual Bleeding, run by Rejoni Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: Within 7 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.