Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB) (NCT06634719) | Clinical Trial Compass
RecruitingNot Applicable
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
United States7 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion 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.
Exclusion criteria
✕. 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.