Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol

Study Overview
=================
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.

Official Title
-----------------
Prospective, Open-label, Multicenter, Multinational, Randomized Trial to Investigate the Non-inferiority of Treatment With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol in a Panel of Post-menopausal Women Suffering From the Symptoms of Vulvovaginal Dryness in a Parallel Group Design

Conditions
-----------------
Vulvovaginal Atrophy

Intervention / Treatment
-----------------
* Device: WO2085 Moisturising Cream
* Drug: Estriol Cream 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Device: WO2085 Moisturising Cream<br>WO2085 is a hormone-free Moisturizing Cream and is used to treat vulvovaginal dryness symptoms. | Device: WO2085 Moisturising Cream<br>* 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).<br>|
| Active Comparator: Drug: Estriol Cream 0.1%<br>Estriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women. | Drug: Estriol Cream 0.1%<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, after 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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. | 6 weeks | 
| Adverse Events | Adverse events will be documented on Visits after 3 and 6 weeks, respectively (and in the patient diary, if applicable). | after 3 and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vulvovaginal Dryness