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

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

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.

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Atrophy
• Intervention / Treatment: Device: Non-hormonal vaginal device therapy; Device: Sham vaginal device therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2065
      • North Shore Private Hospital
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Goldfields Urology
    • Melbourne, Victoria, Australia, 3052
      • Royal Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-hormonal device therapy; Daily non-hormonal device therapy	Device: Non-hormonal vaginal device therapy; Experimental Active Therapy
Sham Comparator: Sham Therapy; Daily non-hormonal sham device therapy	Device: Sham vaginal device therapy; Sham Comparator

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE)	1 year
Patient Satisfaction with Treatment: Likert Scale	Patient satisfaction assessed on Likert Scale - a scoring from 0 to 3 (0=not satisfied, 1=neutral, 2=satisfied, 3=extremely satisfied)	6 months and 1 year

Collaborators and Investigators

• Sponsor: Madorra
• Investigators: Principal Investigator: Rodney Baber, MD, North Shore Private Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: CLN-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes