vaginal atrophy
Conditions
Interventions
During the first week of treatment, 2 ml of the assigned study product will be applied intravaginally 2 times per day. In the next 11 weeks, 2 ml of the assigned study product will be applied 3 times/
Sponsors
BioClin BV, Delft, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: ≥ 1 year past their last menstruation Experiencing at least one of the following complaints of vaginal dryness: vaginal dryness irritation/burning, itch or dyspareunia due to vaginal atrophy related to post-menopause that is moderate or severe in intensity (moderate to severe is defined as a grade of ≥ 4 on a scale of 0-10). Microscopic atrophy eligibility criterion: < 5% superficial cells.
Exclusion criteria
Exclusion criteria: Any local or systemic current hormone-replacement therapy are used or used in the past 6 months Any local medication or treatment is used for relief of the complaints related to vaginal dryness. Use of any medication to treat bacterial vaginosis or vaginal candidiasis in the past 30 days. Current or recent episode of urogenital cancer Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of LiquiGel to relief vaginal dryness as reported by the patient compared to placebo control. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of LiquiGel to reduce discomforts related to post-menopausal atrophy other than 'vaginal dryness' as reported by the patient The efficacy of LiquiGel to reduce signs of vaginal atrophy as reported by the physician The efficacy of LiquiGel to improve cytological outcomes related to vaginal atrophy Improvement of signs and symptoms over time General patient satisfaction of LiquiGel as compared to placebo | — |
Contacts
Public ContactDiana Pasho
BioClin BV
Outcome results
None listed