NCT04222647CompletedPhase 2
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)
Dr. August Wolff GmbH & Co. KG Arzneimittel1 site in 1 country43 target enrollmentStarted: January 27, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- VMI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
WO533
Experimental
Formulation containing WO533 for intravaginal application
Intervention: WO533 (Drug)
Outcomes
Primary Outcomes
VMI
Time Frame: Day 1 to 43
Change of the Vaginal Maturation Index (VMI)
Secondary Outcomes
- Vaginal pH(Day 1 to 8, day 8 to 43, and day 1 to 43)
- Subjective vulvovaginal atrophy symptoms(Day 1 to 8, day 8 to 43, and day 1 to 43)
- Global judgment of the tolerability by the Investigator(Day 1 to 43)
- Global judgment of the tolerability by the patient(Day 1 to 43)
- Adverse events(Day 1 to 43)
Investigators
Study Sites (1)
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