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.
"Vaginal dryness" is defined as dryness, itching, burning and pain unrelated to sexual intercourse.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
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).
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.
Dr. Gerick
Aachen, Germany
Praxis für die Frau
Mölln, Germany
proDERM Institute for Applied Dermatological Research
Schenefeld, Germany
Praxis für die Frau
Schwarzenbek, Germany
Frauenklinik Inselspital Bern
Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 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.
Time frame: Baseline, after 3 and 6 weeks
Overall impairment of daily life
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)
Time frame: 6 weeks
Global judgement of efficacy
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.
Time frame: 6 weeks
Global judgement of tolerability
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.
Time frame: 6 weeks
Adverse Events
Adverse events will be documented on Visits after 3 and 6 weeks, respectively (and in the patient diary, if applicable).
Time frame: after 3 and 6 weeks
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Bern, Switzerland