NCT03044652

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2017-02-07
• Last updated: 2017-07-14

Locations

5 sites across 2 countries: Germany, Switzerland