EUCTR2019-002325-30-DE进行中（未招募）1 期
Prospective, open-label, monocenter, trial to investigate the efficacy and tolerability of Vagisan® a lactic acid containing vaginal suppository, in a panel of post-menopausal women suffering from vulvo vaginal atrophy (VVA)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Post-menopausal women with the subjective symptomatology of vulvovaginal and atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VMI of < 35 at Screening
- •Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit 1.
- •Healthy women as assessed by the medical history or women with well treated chronic disorders (e.g. hypertension, hypercholesterinemia, diabetes, depression etc.).
- •Signed written informed consent before participation in the trial.
- •Willingness to actively participate in the trial and to come to the scheduled visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 43
排除标准
- •Known hypersensitivity against any of the ingredients of the test products.
- •Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (inter alia anti-estrogens) within 3 months before Visit 1 and / or during the conduct of this trial.
- •Local hormonal therapy (vagina/vulva) within 3 months before Visit 1 (also when used for the brightening/pretreatment of cytological smears).
- •Non-healed vaginal surgery.
- •Vaginal inflammation which is not caused by vulvovaginal atrophy.
- •Use of moisturizers (vagina/vulva) within 14 day before Visit 1 and during the conduct of this trial.
- •Any use of products (including lubricants), other than the test product, applied intravaginally or on the vulva during the conduct of this trial.
- •Systemic corticosteroids within 14 days before Visit 1 and during the conduct of this trial (corticoid asthma sprays are allowed).
- •Chronic disease of the genital area, e.g. lichen sclerosus.
- •Patients with known infectious diseases (e.g. hepatitis or HIV infection).
- •Clinically diagnosed vaginal infection (acute or during the conduct of the trial).
- •Use of antibiotics or antimycotics within 14 days before Visit 1 and / or during this trial.
- •Acute drug- or alcohol abuse.
- •Patients with poor compliance and / or poor willingness to cooperate.
- •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
- •Patients, who are inmates of psychiatric wards, prisons or state institutions.
- •Participation in a clinical trial with investigational medicinal products within the last 30 days prior to the start of this study and / or during this trial.
- •Patients underlying any other restrictions due to the participation in other tests / test institutes.
- •Employees of the study sites who are directly involved in this trial or employees of the Sponsor’s company.
- •If in the opinion of the investigator the patient should not participate in the study for any reason
研究者
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