|- candidate number||23632|
|- NTR Number||NTR5667|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jan-2016|
|- Secondary IDs||MGL BH 001 |
|- Public Title||Efficacy of Multi-Gyn LiquiGel for the relief of complaints related to vaginal dryness in post-menopausal women|
|- Scientific Title||A randomized, multi-centre, double blinded, placebo-controlled study of the efficacy of Multi-Gyn LiquiGel for the relief of complaints related to vaginal atrophy in post-menopausal women|
|- hypothesis||Vaginal atrophy in post-menopausal women results in various vaginal complaints, including dryness. Multi-Gyn LiquiGel is a moisturizing gel with osmo-protectant ingredients. We hypothesize that LiquiGel relieves signs and symptoms of vaginal atrophy and improves atrophy scores of vaginal epithelial cells.|
|- Healt Condition(s) or Problem(s) studied||Vaginal atrophy|
|- 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||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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2016|
|- planned closingdate||31-okt-2016|
|- Target number of participants||80|
|- 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/week. |
|- Primary outcome||The efficacy of LiquiGel to relief vaginal dryness as reported by the patient compared to placebo control.|
|- Secondary outcome||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
|- Timepoints||Women will undergo a physical vaginal examination and smears for cytological analysis will be taken after 0, 1, 4 and 12 weeks.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Paul Kwakman|
|- CONTACT for SCIENTIFIC QUERIES|| Paul Kwakman|
|- Sponsor/Initiator ||BioClin BV|
(Source(s) of Monetary or Material Support)
|- Brief summary||With the reduction in estrogen levels that occurs during menopause, physiologic and structural changes occur within the vulvovaginal mucosa that lead to a condition commonly called atrophic vaginitis. In this condition, the cells of the vaginal wall are less developed than in the fertile age, and is often associated with reduced production of vaginal secretions. |
Although mild genital changes occur in most women, 10-47% of postmenopausal women will develop one or more debilitating symptoms that include vulvovaginal dryness, dyspareunia, itching, irritation/burning and intercourse bleeding.
Vaginal moisturizers can provide relief by supplementing the vaginal fluid to help maintain natural secretions, correct the vaginal pH and improves comfort during intercourse. The aim of the current study is to investigate the efficacy of Multi-Gyn LiquiGel to relief vaginal complaints related to post-menopausal atrophy.
|- Main changes (audit trail)|
|- RECORD||20-jan-2016 - 15-apr-2016|