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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Intravaginal application
proDERM Institute for Applied Dermatological Research
Schenefeld, Germany
VMI
Change of the Vaginal Maturation Index (VMI)
Time frame: Day 1 to 43
Vaginal pH
Change of vaginal pH
Time frame: 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
Time frame: 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
Time frame: Day 1 to 43
Global judgment of the tolerability by the patient
Scoring on a scale from 1 to 4
Time frame: Day 1 to 43
Adverse events
Time frame: Day 1 to 43
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