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

Primary Purpose

Vulvovaginal Atrophy

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Non-hormonal vaginal device therapy
Sham vaginal device therapy
Sponsored by
Madorra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Sham Comparator

Arm Label

Non-hormonal device therapy

Sham Therapy

Arm Description

Daily non-hormonal device therapy

Daily non-hormonal sham device therapy

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2021
Last Updated
January 11, 2023
Sponsor
Madorra
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1. Study Identification

Unique Protocol Identification Number
NCT04887701
Brief Title
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Madorra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-hormonal device therapy
Arm Type
Experimental
Arm Description
Daily non-hormonal device therapy
Arm Title
Sham Therapy
Arm Type
Sham Comparator
Arm Description
Daily non-hormonal sham device therapy
Intervention Type
Device
Intervention Name(s)
Non-hormonal vaginal device therapy
Intervention Description
Experimental Active Therapy
Intervention Type
Device
Intervention Name(s)
Sham vaginal device therapy
Intervention Description
Sham Comparator
Primary Outcome Measure Information:
Title
Clinician Assessed Changes in VVA
Description
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.
Time Frame
Baseline to 12 weeks
Title
Patient Reported VAS Score
Description
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.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Responder Rate PGI-I
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of Adverse Events
Description
Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE)
Time Frame
1 year
Title
Patient Satisfaction with Treatment: Likert Scale
Description
Patient satisfaction assessed on Likert Scale - a scoring from 0 to 3 (0=not satisfied, 1=neutral, 2=satisfied, 3=extremely satisfied)
Time Frame
6 months and 1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney Baber, MD
Organizational Affiliation
North Shore Private Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore Private Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Goldfields Urology
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Facility Name
Royal Women's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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