Who is sponsoring NCT03044652?

NCT03044652 is sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel.

What condition does NCT03044652 study?

NCT03044652 studies Vulvovaginal Atrophy.

What drugs are being tested in NCT03044652?

Interventions: WO2085 Moisturising Cream, Estriol Cream 0.1%.

What is the status of NCT03044652?

NCT03044652 is currently COMPLETED.

Last reviewed 2017-07-11 · How we verify

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

NCT03044652 Phase 4 COMPLETED

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.

Details

Lead sponsor	Dr. August Wolff GmbH & Co. KG Arzneimittel
Phase	Phase 4
Status	COMPLETED
Enrolment	172
Start date	2016-11
Completion	2017-06

Conditions

Vulvovaginal Atrophy

Interventions

WO2085 Moisturising Cream
Estriol Cream 0.1%

Primary outcomes

Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks. — Baseline, after 3 and 6 weeks
"Vulvovaginal dryness" will be measured by the Total Severity Score. It is defined as the sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse, each scored from 0=none to 4=very severe. In total a range of 0=no complaints to 16=very severe complaints is possible. Differences to Baseline (Visit 1) of the Total Severity Score assessed after six weeks of treatment (Visit 3) serve as the primary endpoint for the test of non-inferiority.

Countries

Germany, Switzerland