Back to resultsInvestigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA
Primary Purpose
Vulvovaginal Atrophy
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
WO533
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy
Eligibility Criteria
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
Sites / Locations
- proDERM Institute for Applied Dermatological Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WO533
Arm Description
Formulation containing WO533 for intravaginal application
Outcomes
Primary Outcome Measures
VMI
Change of the Vaginal Maturation Index (VMI)
Secondary Outcome Measures
Vaginal pH
Change of vaginal pH
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
Global judgment of the tolerability by the Investigator
Scoring on a scale from 1 to 4
Global judgment of the tolerability by the patient
Scoring on a scale from 1 to 4
Adverse events
Full Information
NCT ID
NCT04222647
First Posted
October 9, 2019
Last Updated
December 22, 2021
Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
proDERM Institut für Angewandte Dermatologische Forschung GmbH, Bremer Pharmacovigilance Service GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04222647
Brief Title
Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
proDERM Institut für Angewandte Dermatologische Forschung GmbH, Bremer Pharmacovigilance Service GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WO533
Arm Type
Experimental
Arm Description
Formulation containing WO533 for intravaginal application
Intervention Type
Drug
Intervention Name(s)
WO533
Intervention Description
Intravaginal application
Primary Outcome Measure Information:
Title
VMI
Description
Change of the Vaginal Maturation Index (VMI)
Time Frame
Day 1 to 43
Secondary Outcome Measure Information:
Title
Vaginal pH
Description
Change of vaginal pH
Time Frame
Day 1 to 8, day 8 to 43, and day 1 to 43
Title
Subjective vulvovaginal atrophy symptoms
Description
Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) and as sum score
Time Frame
Day 1 to 8, day 8 to 43, and day 1 to 43
Title
Global judgment of the tolerability by the Investigator
Description
Scoring on a scale from 1 to 4
Time Frame
Day 1 to 43
Title
Global judgment of the tolerability by the patient
Description
Scoring on a scale from 1 to 4
Time Frame
Day 1 to 43
Title
Adverse events
Time Frame
Day 1 to 43
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirstin Deuble-Bente, MD
Organizational Affiliation
proDERM Institute for Applied Dermatological Research, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
proDERM Institute for Applied Dermatological Research
City
Schenefeld
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA
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