A Prospective Multicenter Safety and Feasibility Study of the Juveena Hydrogel System for Use for Temporary Control of Chronic Ovulatory Heavy Menstrual Bleeding (HMB)
Overview
- Phase
- Not Applicable
- Intervention
- Juveena Hydrogel System
- Conditions
- Heavy Menstrual Bleeding
- Sponsor
- Rejoni Inc.
- Enrollment
- 7
- Locations
- 8
- Primary Endpoint
- Primary Effectiveness Endpoint
- Status
- Recruiting
- Last Updated
- 5 days ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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.
- •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)
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.
- •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
Arms & Interventions
Juveena Hydrogel System
One time instillation of the Juveena Hydrogel into the uterine cavity.
Intervention: Juveena Hydrogel System
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint
Time Frame: Within 7 days post-treatment
Feasibility for invoking a tamponade effect