Vulvovaginal Atrophy
Conditions
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.
Detailed 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.
Interventions
DEVICENon-hormonal vaginal device therapy
Experimental Active Therapy
DEVICESham vaginal device therapy
Sham Comparator
Sponsors
Madorra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Assessed Changes in VVA | 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. |
| Patient Reported VAS Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate PGI-I | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 1 year | Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) |
| Patient Satisfaction with Treatment: Likert Scale | 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) |
Countries
Australia
Outcome results
None listed