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

NCT ID: NCT04222647

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-27

Study Completion Date

2020-08-11

Brief Summary

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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

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Conditions

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Vulvovaginal Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WO533

Formulation containing WO533 for intravaginal application

Group Type EXPERIMENTAL

WO533

Intervention Type DRUG

Intravaginal application

Interventions

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WO533

Intravaginal application

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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proDERM Institut für Angewandte Dermatologische Forschung GmbH

UNKNOWN

Sponsor Role collaborator

Bremer Pharmacovigilance Service GmbH

OTHER

Sponsor Role collaborator

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirstin Deuble-Bente, MD

Role: PRINCIPAL_INVESTIGATOR

proDERM Institute for Applied Dermatological Research, Germany

Locations

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proDERM Institute for Applied Dermatological Research

Schenefeld, , Germany

Site Status

Countries

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Germany

References

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Gabes M, Donhauser T, Harder A, Masur C, Apfelbacher CJ. Psychometric evaluation of the German Day-to-Day Impact of Vaginal Aging questionnaire using data from two intervention studies. Menopause. 2023 May 1;30(5):551-555. doi: 10.1097/GME.0000000000002161. Epub 2023 Feb 14.

Reference Type DERIVED
PMID: 36787527 (View on PubMed)

Other Identifiers

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2019-002325-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VMP-03/2018

Identifier Type: -

Identifier Source: org_study_id