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

NCT04887701 | Completed DMC FDA Device

• 1 other identifier: CLN-201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Responder Rate PGI-I

  12 weeks

Other Outcomes (2)

• Incidence of Adverse Events

  1 year

• Patient Satisfaction with Treatment: Likert Scale

  6 months and 1 year

Study Arms (2)

Non-hormonal device therapy

EXPERIMENTAL

Daily non-hormonal device therapy

Device: Non-hormonal vaginal device therapy

Sham Therapy

SHAM COMPARATOR

Daily non-hormonal sham device therapy

Device: Sham vaginal device therapy

Interventions

Non-hormonal vaginal device therapy DEVICE

Experimental Active Therapy

Non-hormonal device therapy

Sham vaginal device therapy DEVICE

Sham Comparator

Sham Therapy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madorra: lead

Study Sites (3)

North Shore Private Hospital

Sydney, New South Wales, 2065, Australia

Location

Goldfields Urology

Bendigo, Victoria, 3550, Australia

Location

Royal Women's Hospital

Melbourne, Victoria, 3052, Australia

Location

Related Publications (1)

• Hickey M, Baber R, Eden J, Brennan J, Bateson D, Goldman M, Rockweiler H, Dreon D. Safety and effectiveness of a novel home-use therapeutic ultrasound device for the treatment of vaginal dryness in postmenopausal women: a pilot study. Menopause. 2023 Apr 1;30(4):383-392. doi: 10.1097/GME.0000000000002157. Epub 2023 Feb 8.

  PMID: 36749915 DERIVED

Study Officials

• Rodney Baber, MD

  North Shore Private Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: July 9, 2021
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)