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

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)

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.

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Atrophy
• Intervention / Treatment: Drug: WO533

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany
    • proDERM Institute for Applied Dermatological Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WO533; Formulation containing WO533 for intravaginal application	Drug: WO533; Intravaginal application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VMI	Change of the Vaginal Maturation Index (VMI)	Day 1 to 43

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal pH	Change of vaginal pH	Day 1 to 8, day 8 to 43, and day 1 to 43
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
Global judgment of the tolerability by the Investigator	Scoring on a scale from 1 to 4	Day 1 to 43
Global judgment of the tolerability by the patient	Scoring on a scale from 1 to 4	Day 1 to 43
Adverse events		Day 1 to 43

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: proDERM Institut für Angewandte Dermatologische Forschung GmbH; Bremer Pharmacovigilance Service GmbH
• Investigators: Principal Investigator: Kirstin Deuble-Bente, MD, proDERM Institute for Applied Dermatological Research, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Actual): August 11, 2020
• Study Completion (Actual): August 11, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: VMP-03/2018; 2019-002325-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No