Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol
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|ClinicalTrials.gov Identifier: NCT03044652|
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Vulvovaginal Atrophy||Device: WO2085 Moisturising Cream Drug: Estriol Cream 0.1%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Medical Device: WO2085 Moisturising Cream
WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
Device: WO2085 Moisturising Cream
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).
Active Comparator: Drug: Estriol Cream 0.1%
Estriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women.
Drug: Estriol 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.
- Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks. [ Time Frame: 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.
- Overall impairment of daily life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044652
|Praxis für die Frau|
|proDERM Institute for Applied Dermatological Research|
|Praxis für die Frau|
|Frauenklinik Inselspital Bern|
|Study Director:||Prof. Christoph Abels, MD, PhD||Dr. August Wolff GmbH & Co. KG Arzneimittel|
|Principal Investigator:||Prof. Petra Stute, MD, PhD||Universitätsklinik für Frauenheilkunde, Inselspital Bern|
|Principal Investigator:||Kirstin Deuble-Bente, MD||proDERM Institute for Applied Dermatological Research, Germany|