Status:
COMPLETED
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Lead Sponsor:
Madorra
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
21-65 years
Phase:
NA
Brief 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.
Detailed Description
After screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. After the primary endpoint evaluation at week 12, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04887701
Start Date
July 9 2021
End Date
August 22 2022
Last Update
January 13 2023
Active Locations (3)
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1
North Shore Private Hospital
Sydney, New South Wales, Australia, 2065
2
Goldfields Urology
Bendigo, Victoria, Australia, 3550
3
Royal Women's Hospital
Melbourne, Victoria, Australia, 3052