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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002325-30 | EudraCT Number |
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| Name | Class |
|---|---|
| proDERM Institut für Angewandte Dermatologische Forschung GmbH | UNKNOWN |
| Bremer Pharmacovigilance Service GmbH | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WO533 | Experimental | Formulation containing WO533 for intravaginal application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WO533 | Drug | Intravaginal application |
|
| Measure | Description | Time Frame |
|---|---|---|
| VMI | Change of the Vaginal Maturation Index (VMI) | Day 1 to 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal pH | Change of vaginal pH | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente, MD | proDERM Institute for Applied Dermatological Research, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proDERM Institute for Applied Dermatological Research | Schenefeld | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787527 | Derived | 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. |
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| 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 | Day 1 to 43 |
| Global judgment of the tolerability by the patient | Scoring on a scale from 1 to 4 | Day 1 to 43 |
| Adverse events | Day 1 to 43 |