Medical Device Study to Investigate the Efficacy and Tolerability of Vagisan® Moisturising Cream vs. Gynomunal® Vaginal Gel in a 2-period Changeover Design in n=120 Patients With Vaginal Dryness Who Cannot or do Not Wish to Use Oestrogens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 12
- 主要终点
- per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain)
研究概览
简要总结
Vulvovaginal irritation due to dryness is a frequent complaint among post- and some premenopausal women. International guidelines recommend non-hormonal products as first line therapy.
Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised, two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.
The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects were planned to be assessed. 120 women should be randomly allocated to either of the two treatments, each given over a period of 4 weeks.
详细描述
The purpose of the study was to test the non-inferiority of the medical device Vagisan® Moisturising Cream (VMC) in comparison to Gynomunal® vaginal gel (GVG) in 6 centres in 120 women who suffered from "vaginal dryness". The main objective criterion was to compare the sum of 4 subjective symptoms of "vaginal dryness" measured daily over a period of 28 days. VMC should be applied daily, while GVG had to be administered daily during the first week and twice weekly thereafter.
The main objective parameter for efficacy analysis was the sum of the subjective symptoms of vaginal dryness (feeling of dryness, itching, burning sensation and pain) before, during (patient diaries) and after the 28-day therapy period.
The per-protocol analysis and of the intent-to-treat analysis should prove non-inferiority of VMC compared to GVG, despite a possible carry-over effect to the detriment of VMC. To avoid the problem of any possible carry-over effect the analysis of the first period was chosen for the primary comparison of both products.
Furthermore, objective symptoms of vaginal dryness detected via colposcopy, the vaginal secretion's pH, the efficacy assessment by the patients and the treating doctor and patients' questionnaires with regard to the product characteristics of the medical devices should be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over the age of
- •Women with vaginal dryness who do not want to or are not allowed to use oestrogens, such as post-menopausal women, women with oestrogen-dependent tumours in their medical history and women who had been treated with systemic medicinal products that can have a drying-out effect on the vaginal mucous membranes.
- •Total score (0-16) of at least 3 of four subjective symptoms (feeling of dryness, itching, burning sensation and pain).
- •Written declaration of consent for the voluntary participation in the study is present.
排除标准
- •Known hypersensitivity to one of the ingredients of the test and/or reference medical device.
- •Current vaginal infections.
- •Recurring (i.e. at least 3) vaginal infections within the last 12 months.
- •Additional (not study-related) treatment of vaginal dryness during the therapy phases.
- •Therapy with antibiotics, steroids (excluding sexual steroids in oral, dermal or transdermal application) or antimycotics in the last 14 days before inclusion and participation in this study.
- •Women who are not able to participate properly in this study.
- •Fertile women without sufficient contraceptive protection.
- •Fertile women who are pregnant (positive HCG test) or breastfeeding.
- •Current alcohol and/or drug abuse.
- •Participation in another clinical study within the last four weeks and/or parallel participation in this study.
研究组 & 干预措施
Vagisan® Moisturising Cream
non-hormonal vaginal cream for the treatment of vulvovaginal dryness
干预措施: Vagisan® Moisturising Cream (Device)
Gynomunal® vaginal gel
non-hormonal gel
干预措施: Gynomunal® vaginal gel (Device)
结局指标
主要结局
per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain)
时间窗: Therapy period of 28 days
The main objective criterion for the confirmatory analysis was the per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced) during the course of therapy. This was based on the daily entry in the patient diary.
次要结局
- Intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses(28 days)
- Patients' individual subjective symptoms of "vaginal dryness"(28 days)
- Overall efficacy and tolerability assessments(28 days)
- Occurrence of side effects(28 days)
- Assessment of adverse events(28 days)
- Vaginal pH(28 days)
- Patients' subjective satisfaction with the test and reference medical device(28 days)