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

PHASE4CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Vulvovaginal Atrophy
Interventions
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).

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.

Trial Locations (5)

Unknown

Dr. Gerick, Aachen

Praxis für die Frau, Mölln

proDERM Institute for Applied Dermatological Research, Schenefeld

Praxis für die Frau, Schwarzenbek

Frauenklinik Inselspital Bern, Bern

All Listed Sponsors
collaborator

proDERM Institut für Angewandte Dermatologische Forschung GmbH

UNKNOWN

collaborator

Bremer Pharmacovigilance Service GmbH

OTHER

collaborator

GCP-Service International Ltd. & Co. KG

INDUSTRY

lead

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY

NCT03044652 - Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol | Biotech Hunter | Biotech Hunter