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

Dr. August Wolff

Status and phase

Completed

Phase 4

Conditions

Vulvovaginal Atrophy

Treatments

Device: WO2085 Moisturising Cream

Drug: Estriol Cream 0.1%

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03044652

VFCr-12/2015

2016-002199-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

"Vaginal dryness" is defined as dryness, itching, burning and pain unrelated to sexual intercourse.

Enrollment

172 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).