Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women (NCT04887701) | Clinical Trial Compass
CompletedNot Applicable
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Australia25 participantsStarted 2021-07-09
Plain-language summary
Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.
Who can participate
Age range
21 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treatmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.