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

Phase 2

Completed

• Conditions: Vulvovaginal Atrophy
• Interventions: Drug: WO533

• Registration Number: NCT04222647
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-10
• Study Start: 2020-01-27
• Primary Completion: 2020-08-11
• Study Completion: 2020-08-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WO533	WO533	Formulation containing WO533 for intravaginal application

Primary Outcome Measures

Name	Time	Method
VMI	Day 1 to 43	Change of the Vaginal Maturation Index (VMI)

Secondary Outcome Measures

Name	Time	Method
Global judgment of the tolerability by the patient	Day 1 to 43	Scoring on a scale from 1 to 4
Adverse events	Day 1 to 43
Global judgment of the tolerability by the Investigator	Day 1 to 43	Scoring on a scale from 1 to 4
Vaginal pH	Day 1 to 8, day 8 to 43, and day 1 to 43	Change of vaginal pH
Subjective vulvovaginal atrophy symptoms	Day 1 to 8, day 8 to 43, and day 1 to 43	Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) and as sum score

Trial Locations

Locations (1)

proDERM Institute for Applied Dermatological Research; 🇩🇪 Schenefeld, Germany