Vulvovaginal Atrophy
Conditions
Keywords
Vulvovaginal Dryness
Brief summary
The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol.
Detailed description
Vaginal dryness is defined as dryness, itching, burning and pain unrelated to sexual intercourse.
Interventions
2.5 g of the investigational product WO2085 Moisturising Cream will be applied intravaginally, once daily in the evening. After improvement of the symptoms the frequency may be reduced by the patient as needed. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day).
DRUGEstriol Cream 0.1%
0.5 g of the reference product Estriol Cream 0.1% will be applied intravaginally once daily in the evening for the first 3 weeks. Subsequently, the frequency will be reduced to twice a week for the last 3 weeks for all patients in this treatment group.
Sponsors
proDERM Institut für Angewandte Dermatologische Forschung GmbH
Bremer Pharmacovigilance Service GmbH
GCP-Service International Ltd. & Co. KG
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post-menopausal women with the subjective symptoms of vulvovaginal dryness with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VAS value Overall impairment of daily life due to the condition vulvovaginal dryness \> 0 on Visit 1. * Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit 1. * Physical and mental healthy women as assessed by the medical history. * PAP test performed within the last 12 months before Visit 1 and result less than PAP III. * Signed written informed consent before participation in the Trial. * Willingness to actively participate in the trial and to come to the scheduled visits.
Exclusion criteria
* Known hypersensitivity against any of the ingredients of the test products. * Any indication in the medical history regarding an impairment of the hepatic, renal, gastrointestinal, cardiovascular, pulmonary, endocrinological or hematological system (especially venous and arterial thromboembolism, ischemic stroke, myocardial infarction, porphyria) if clinically relevant for this clinical trial (cf. contraindications and warnings for Estriol cream 0.1%). * Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency). * Breast cancer (acute and / or in the medical history or suspected). * Estrogen-dependent tumor (acute and / or in the medical history or suspected, especially ovarian and / or endometrial carcinoma). * 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. * Intrauterine device (IUD) with progestogen (Mirena®, Jaydess®) * Pathological findings in cancer screening (Papanicolaou III, III D - V in the cervical test) * Pathological changes in the vaginal or cervix area, which are caused by estrogen deficiency (except symptoms and condition of vulvovaginal dryness), e.g. diminution of labia caused by estrogen deficiency, constricted introitus. * Patients with known infectious diseases (e.g. hepatitis or HIV infection).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Total Severity Score of the Treatment of vulvovaginal dryness at 6 weeks. | Baseline, after 3 and 6 weeks | Vulvovaginal dryness will be measured by the Total Severity Score. It is defined as the sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse, each scored from 0=none to 4=very severe. In total a range of 0=no complaints to 16=very severe complaints is possible. Differences to Baseline (Visit 1) of the Total Severity Score assessed after six weeks of treatment (Visit 3) serve as the primary endpoint for the test of non-inferiority. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall impairment of daily life | 6 weeks | Overall impairment of daily life due to the condition vaginal dryness (including subgroup analysis of patients with mild, moderate or severe impairment) will be measured by using a Visual Analogue Scale (VAS) |
| Global judgement of efficacy | 6 weeks | The global judgement of efficacy will be assessed by the investigator and the patient according to the following scale: 1=very good to 4=poor. |
| Global judgement of tolerability | 6 weeks | The global judgement of tolerability will be assessed by the investigator and the patient according to the following scale: 1=very good to 4=poor. |
| Adverse Events | after 3 and 6 weeks | Adverse events will be documented on Visits after 3 and 6 weeks, respectively (and in the patient diary, if applicable). |
Countries
Germany, Switzerland
Outcome results
None listed