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

Dr. August Wolff

Status and phase: Completed; Phase 2

Conditions: Vulvovaginal Atrophy

Treatments: Drug: WO533

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04222647

2019-002325-30 (EudraCT Number)

VMP-03/2018

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

WO533

Experimental group

Description:

Formulation containing WO533 for intravaginal application

Treatment:

Drug: WO533