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

NCT03044652 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2017-07-14

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • proDERM Institut für Angewandte Dermatologische Forschung GmbH

    collaborator UNKNOWN

  • Bremer Pharmacovigilance Service GmbH

    collaborator OTHER

  • GCP-Service International Ltd. & Co. KG

    collaborator INDUSTRY

  • Dr. August Wolff GmbH & Co. KG Arzneimittel

    lead INDUSTRY

Principal Investigators

  • Prof. Christoph Abels, MD, PhD · Dr. August Wolff GmbH & Co. KG Arzneimittel

  • Prof. Petra Stute, MD, PhD · Universitätsklinik für Frauenheilkunde, Inselspital Bern

  • Kirstin Deuble-Bente, MD · proDERM Institute for Applied Dermatological Research, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044652 on ClinicalTrials.gov