Skip to main content
OpenTrials
Completed

NCT Number: NCT04887701

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vulvovaginal Atrophy

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

North Shore Private Hospital, Sydney, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-hormonal vaginal device therapy

Device

Experimental Active Therapy

Sham vaginal device therapy

Device

Sham Comparator

Primary outcomes

  1. Clinician Assessed Changes in VVA

    Time frame: Baseline to 12 weeks

    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.

  2. Patient Reported VAS Score

    Time frame: Baseline to 12 weeks

    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 outcomes

  1. Responder Rate PGI-I

    Time frame: 12 weeks

    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.

Other outcomes

  1. Incidence of Adverse Events

    Time frame: 1 year

    Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE)

  2. Patient Satisfaction with Treatment: Likert Scale

    Time frame: 6 months and 1 year

    Patient satisfaction assessed on Likert Scale - a scoring from 0 to 3 (0=not satisfied, 1=neutral, 2=satisfied, 3=extremely satisfied)

Sponsors and collaborators

Lead sponsor

Madorra

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 14, 2021
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.