Vulvovaginal Atrophy
Conditions
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.
Interventions
DRUGWO533
Intravaginal application
Sponsors
proDERM Institut für Angewandte Dermatologische Forschung GmbH
Bremer Pharmacovigilance Service GmbH
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VMI | Day 1 to 43 | Change of the Vaginal Maturation Index (VMI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal pH | Day 1 to 8, day 8 to 43, and day 1 to 43 | Change of vaginal pH |
| Subjective vulvovaginal atrophy symptoms | Day 1 to 8, day 8 to 43, and day 1 to 43 | 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 | Day 1 to 43 | Scoring on a scale from 1 to 4 |
| Global judgment of the tolerability by the patient | Day 1 to 43 | Scoring on a scale from 1 to 4 |
| Adverse events | Day 1 to 43 | — |
Countries
Germany
Outcome results
None listed