Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)

Launched by AVETA MEDICAL · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the VITA AV Clinical System, which is designed to help post-menopausal women who experience painful intercourse, a condition known as Genitourinary Syndrome of Menopause (GSM). The trial aims to see how safe and effective this device is over three months compared to a sham (or placebo) device. Eligible participants are healthy post-menopausal women who have been without their menstrual cycle for at least one year and have moderate to severe pain during sex. They should also be sexually active and plan to engage in sexual activity at least twice a month during the study.

If you decide to participate, you'll need to avoid using other treatments for GSM symptoms during the trial and follow specific guidelines, such as not engaging in sexual intercourse for 48 hours before visits. The study will include follow-up visits to check how well the device works over time and to ensure your safety. It's important to note that there are certain health conditions and treatments that may prevent someone from joining the trial, so discussing your health history with the study team will be essential.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cycle.
• • 2. Willingness to refrain from using alternative therapies for treatment of symptoms of GSM, unless medically necessary, through the duration of this study.
• • 3. Moderate to severe dyspareunia associated with GSM. (i.e., ≥4 on the 11-point patient-reported numeric rated dyspareunia scale).
• • 4. Subjects who are sexually active (i.e. have had or have attempted to have sexual activity with vaginal penetration within approximately 1 month of screening visit).
• • 5. Subjects who anticipate engaging or attempting to engage in sexual activity (with vaginal penetration) at least twice a month during the trial.
• • 6. Vaginal Health Index (VHI) score of less than or equal to 15.
• • 7. Vaginal pH \>5.0.
• • 8. The subject is anatomically suitable to the intravaginal tip as determined by the Investigator.
• • 9. Normal Papanicolaou test within the past year (or should be done 2 weeks before the trial begins). Subject can ONLY participate on negative results.
• • 10. Vaginal canal free of any lesions other than symptoms of GSM as determined by the Investigator.
• • 11. Negative screening for chlamydia, gonorrhea, bacterial vaginosis, trichomonas and yeast.
• • 12. Willingness and ability to give voluntary written informed consent to participate in the study and comply with protocol requirements.
• • 13. Willingness to refrain from sexual intercourse for at least 48 hours before all visits and for at least 48 hours after all treatments.
• • 14. Willingness to stop using current vaginal lubricant, moisturizers or similar and only use the lubricant provided by the clinic.
• • 15. Willingness to stop using the clinic assigned lubricant for at least 48 hours before all scheduled visits post screening.
• • 16. Willingness to refrain from any pelvic floor therapy for the duration of the trial.
• • 17. Willingness to refrain from enrolling in another clinical trial for the duration of this study.
• Exclusion Criteria:
• • 1. Subjects on Hormone Therapies (HT), systemic or local, or within 6 months of cessation of HT prior to inclusion in the study.
• • 2. Subjects with bleeding disorders.
• • 3. Subjects with any sexually transmitted disease.
• • 4. Subjects on prescribed anticoagulants such as antiplatelets and anticoagulants (Heparin, Warfarin, Clopidogrel, Apixaban, Rivaroxaban).
• • 5. Any active genital infections.
• • 6. Abnormal Papanicolaou test within the past year.
• • 7. Positive pregnancy test or planned pregnancy during the study period.
• • 8. Complete procidentia or prolapse that in investigator opinion would be unsuitable for probe placement.
• • 9. Subjects with urogenital sinus (this is when urethral opening is combined with the vagina opening), otherwise the urethral opening will be traumatized potentially resulting in a urinary tract infection (UTI).
• • 10. Subjects with a compromised immune system.
• • 11. Subjects who have undergone pelvic irradiation treatment.
• • 12. Subjects who have undergone off-label procedures such as "vaginal rejuvenation" (e.g., laser or thermoablative techniques).
• • 13. Pelvic surgery within 6 months prior to the start of the study.
• • 14. Undiagnosed vaginal bleeding.
• • 15. Subjects with bleeding during screening examination due to friable vaginal mucosa and/or very thin epithelial layer, such that investigator determines the VITA AV treatment would be contraindicated.
• • 16. Subjects receiving chemotherapy or radiotherapy or subjects with any diagnosed gynecological cancers.
• • 17. History of breast cancer who have had chemotherapy within the last 5 years or are on aromatase inhibitors.
• • 18. Any general health or anatomical conditions, mental health or social situation which, in the opinion of the investigator, could represent an increased risk for the subject, or the ability of the subject to complete study requirements.
• • 19. Currently participating or considering participation in any other research of an investigational drug or device. Does not include observational studies.
• • 20. Subjects that have previously received this treatment as part of a clinical trial.