BridgeMD
New treatment option for Heavy Menstrual Bleeding
Official title Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
ClinicalTrials.gov ID: NCT06634719
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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...
- Demonstrates understanding of the study and signs the written informed consent form.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- West Orange, New Jersey, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; West Orange, New Jersey, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.