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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04887701




Registration number
NCT04887701
Ethics application status
Date submitted
10/05/2021
Date registered
14/05/2021
Date last updated
13/01/2023

Titles & IDs
Public title
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Scientific 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
Secondary ID [1] 0 0
CLN-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvovaginal Atrophy 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Non-hormonal vaginal device therapy
Treatment: Devices - Sham vaginal device therapy

Experimental: Non-hormonal device therapy - Daily non-hormonal device therapy

Sham comparator: Sham Therapy - Daily non-hormonal sham device therapy


Treatment: Devices: Non-hormonal vaginal device therapy
Experimental Active Therapy

Treatment: Devices: Sham vaginal device therapy
Sham Comparator
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinician Assessed Changes in VVA
Timepoint [1] 0 0
Baseline to 12 weeks
Primary outcome [2] 0 0
Patient Reported VAS Score
Timepoint [2] 0 0
Baseline to 12 weeks
Secondary outcome [1] 0 0
Responder Rate PGI-I
Timepoint [1] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
21 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2022
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
North Shore Private Hospital - Sydney
Recruitment hospital [2] 0 0
Goldfields Urology - Bendigo
Recruitment hospital [3] 0 0
Royal Women's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
3550 - Bendigo
Recruitment postcode(s) [3] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Madorra
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04887701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rodney Baber, MD
Address 0 0
North Shore Private Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04887701