Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Vulvovaginal Atrophy
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy
Eligibility Criteria
Inclusion Criteria: Women with menopause defined by last menstrual period at least 12 months prior to screening, or 6 months of amenorrhea with serum FSH levels > 40 mIU/ml, or 8 weeks postsurgical bilateral oophorectomy with or without hysterectomy. Sexually active women. Participant experiencing subjective moderate-to-severe vaginal pain with sexual intercourse. Participant experiencing subjective moderate-to-severe vaginal dryness. Gynecological exam confirming vaginal atrophy. Willingness to give voluntary written informed consent to participate in the study and comply with protocol requirements. Exclusion Criteria: Use of systemic or local estrogen therapy, currently or in the last 6 months or planned use during the study. Use of any other treatment for vaginal atrophy, 6 weeks prior to enrollment or planned during the study period. Investigational drugs and also prescription and nonprescription medications/remedies known to treat VVA within 60 days of enrollment or during the study. Vaginal stenosis. Pelvic floor disorders. Prior pelvic radiation therapy including radiation or surgery to the vulva/vagina. Active urinary tract, yeast, or other active gynecologic infections. Active connective tissue disorders such as lupus or Sjogren's syndrome. Active malignancies. Diagnosis of vulvodynia or other pelvic pain in the vagina or vulvar area. Vulvar dermatoses. Laser or radio frequency vaginal rejuvenation treatment or planned treatment during the study. Any medical condition that, in the investigator's opinion, would interfere with their participation and/or completion in the study.
Sites / Locations
- North Shore Private Hospital
- Goldfields Urology
- Royal Women's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Non-hormonal device therapy
Sham Therapy
Daily non-hormonal device therapy
Daily non-hormonal sham device therapy