Clinical trial NCT03044652: Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal Dryness
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: proDERM Institut für Angewandte Dermatologische Forschung GmbH
name: Bremer Pharmacovigilance Service GmbH
name: GCP-Service International Ltd. & Co. KG
First posted: 2017-02-07
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks.
timeFrame: Baseline, after 3 and 6 weeks
Secondary outcomes:
measure: Overall impairment of daily life
timeFrame: 6 weeks
measure: Global judgement of efficacy
timeFrame: 6 weeks
measure: Global judgement of tolerability
timeFrame: 6 weeks
measure: Adverse Events
timeFrame: after 3 and 6 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Dr. Gerick
city: Mölln
country: Germany
facility: Praxis für die Frau
city: Schenefeld
country: Germany
facility: proDERM Institute for Applied Dermatological Research
city: Schwarzenbek
country: Germany
facility: Praxis für die Frau
city: Bern
country: Switzerland
facility: Frauenklinik Inselspital Bern
Study officials:
affiliation: Dr. August Wolff GmbH & Co. KG Arzneimittel
name: Prof. Christoph Abels, MD, PhD
role: STUDY_DIRECTOR
affiliation: Universitätsklinik für Frauenheilkunde, Inselspital Bern
name: Prof. Petra Stute, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: proDERM Institute for Applied Dermatological Research, Germany
name: Kirstin Deuble-Bente, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995 Dec;22 Suppl:S1-S5. doi: 10.1016/0378-5122(95)00956-6.
citation: 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.
citation: Stute P, May TW, Masur C, Schmidts-Winkler IM. Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. Climacteric. 2015;18(4):582-9. doi: 10.3109/13697137.2015.1036854. Epub 2015 May 22.
citation: Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.