Investigation of Non-inferiority of Treatment of Vulvovag... | NCT03044652

ID	Type	Description	Link
2016-002199-28	EudraCT Number

Status Module

Name	Class
proDERM Institut für Angewandte Dermatologische Forschung GmbH	UNKNOWN
Bremer Pharmacovigilance Service GmbH	OTHER
GCP-Service International Ltd. & Co. KG	INDUSTRY

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical Device: WO2085 Moisturising Cream	Experimental	WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.	Device: WO2085 Moisturising Cream
Drug: Estriol Cream 0.1%	Active Comparator	Estriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women.	Drug: Estriol Cream 0.1%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WO2085 Moisturising Cream	Device	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).

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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).

Name	Affiliation	Role
Prof. Christoph Abels, MD, PhD	Dr. August Wolff GmbH & Co. KG Arzneimittel	Study Director
Prof. Petra Stute, MD, PhD	Universitätsklinik für Frauenheilkunde, Inselspital Bern	Principal Investigator
Kirstin Deuble-Bente, MD	proDERM Institute for Applied Dermatological Research, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Gerick		Aachen			Germany
Praxis für die Frau

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8775770	Background	Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995 Dec;22 Suppl:S1-S5. doi: 10.1016/0378-5122(95)00956-6.
20196634	Background	Biglia N, Peano E, Sgandurra P, Moggio G, Panuccio E, Migliardi M, Ravarino N, Ponzone R, Sismondi P. Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. Gynecol Endocrinol. 2010 Jun;26(6):404-12. doi: 10.3109/09513591003632258.