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)
- Conditions
- vulvovaginal atrophyMedDRA version: 21.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophySystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2019-002325-30-DE
- Lead Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 43
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method