Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women

Study Overview
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Brief Summary
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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
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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, each participant in both arms will immediately commence an open label period using an Active device for week 13 to 1 year to collect further effectiveness and safety data.

Official Title
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Clinical Outcomes and Safety of a Non-hormonal Medical Device Versus a Sham Device on the Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women Who Have Failed, Refused, or Are Contraindicated for Hormone Therapy

Conditions
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Vulvovaginal Atrophy

Intervention / Treatment
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* Device: Non-hormonal vaginal device therapy
* Device: Sham vaginal device therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-hormonal device therapy<br>Daily non-hormonal device therapy | Device: Non-hormonal vaginal device therapy<br>* Experimental Active Therapy<br>|
| Sham Comparator: Sham Therapy<br>Daily non-hormonal sham device therapy | Device: Sham vaginal device therapy<br>* Sham Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Assessed Changes in VVA | Will determine by comparing the mean change between the two arms of the study in clinician assessed changes of VVA by the Vaginal Health Index (VHI). The VHI gives a numerical score (1-5) for each of the 5 parameters measured: issue elasticity, vaginal fluid, PH, mucosa, and vaginal moisture. | Baseline to 12 weeks | 
| Patient Reported VAS Score | Mean change in the Vaginal Assessment Scale (VAS). The VAS is a scale from 0 to 3 with 0 being no symptoms and 3 being severe symptoms. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate PGI-I | The proportion of patients in the two arms of the study achieving improvement in the patient global impression of improvement (PGI-I), (much or very much improved) at 12 weeks post-treatment. | 12 weeks |