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NCT04222647 Clinical Trial

Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA

Vulvovaginal Atrophy Clinical Trial

Official title:
Prospective, Open-label, Monocenter, Trial to Investigate the Efficacy and Tolerability of WO533, a Lactic Acid Containing Vaginal Suppository, in a Panel of Post-menopausal Women Suffering From Vulvovaginal Atrophy (VVA)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04222647
Other study ID # VMP-03/2018
Secondary ID 2019-002325-30
Status Completed
Phase Phase 2
First received
Last updated
Start date January 27, 2020
Est. completion date August 11, 2020

Study information
Verified date December 2021
Source Dr. August Wolff GmbH & Co. KG Arzneimittel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date August 11, 2020
Est. primary completion date August 11, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Post-menopausal women with subjective symptomatology of vulvovaginal atrophy - Signed written informed consent before participation in the trial Exclusion Criteria: - Known hypersensitivity against any of the ingredients of the investigational product - Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial - Local hormonal therapy (vagina/vulva) within 3 months before the trial - If in the opinion of the investigator the patient should not participate in the study for any reason

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• WO533
Intravaginal application

Locations
Country Name City State
Germany proDERM Institute for Applied Dermatological Research Schenefeld

Sponsors (3)
Lead Sponsor Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel Bremer Pharmacovigilance Service GmbH, proDERM Institut für Angewandte Dermatologische Forschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary VMI Change of the Vaginal Maturation Index (VMI) Day 1 to 43
Secondary Vaginal pH Change of vaginal pH Day 1 to 8, day 8 to 43, and day 1 to 43
Secondary Subjective vulvovaginal atrophy symptoms Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) and as sum score Day 1 to 8, day 8 to 43, and day 1 to 43
Secondary Global judgment of the tolerability by the Investigator Scoring on a scale from 1 to 4 Day 1 to 43
Secondary Global judgment of the tolerability by the patient Scoring on a scale from 1 to 4 Day 1 to 43
Secondary Adverse events Day 1 to 43
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