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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Experimental Active Therapy
Sham Comparator
North Shore Private Hospital
Sydney, New South Wales, Australia
Goldfields Urology
Bendigo, Victoria, Australia
Royal Women's Hospital
Melbourne, Victoria, Australia
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.
Time frame: 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.
Time frame: Baseline to 12 weeks
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.
Time frame: 12 weeks
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