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

Vulvovaginal Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887701
• Other study ID #: CLN-201
• Status: Completed
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: August 22, 2022

Study information

• Verified date: January 2023
• Source: Madorra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

Device:
• Non-hormonal vaginal device therapy
Experimental Active Therapy
• Sham vaginal device therapy
Sham Comparator

Locations

Country	Name	City	State
Australia	Goldfields Urology	Bendigo	Victoria
Australia	Royal Women's Hospital	Melbourne	Victoria
Australia	North Shore Private Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Madorra

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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