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| Name | Class |
|---|---|
| Turun Gynekologikeskus Oy | UNKNOWN |
| The Finnish Funding Agency for Technology and Innovation | OTHER_GOV |
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Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. The objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moisturizing vaginal and vulvar sea buckthorn oil cream | Experimental | Moisturizing non-hormonal vaginal and vulvar cream containing sea buckthorn oil as active ingredient (medical device product in development). Administered twice or once per day for 5 weeks. Post-menopausal women n= 55 + 45. Pre-menopausal women n=15 |
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| Moisturizing vaginal and vulvar cream | Active Comparator | Moisturizing non-hormonal vaginal and vulvar cream (commercial medical device cream already on the market, not containing sea buckthorn oil). Administered once - twice per day for 5 weeks. Postmenopausal women n=55 |
|
| Control | No Intervention | No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moisturizing vaginal and vulvar sea buckthorn oil cream | Device |
| ||
| Moisturizing vaginal and vulvar cream |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture | Baseline, 5 weeks | |
| Change in vaginal and vulvar pH | Baseline, 5 weeks | |
| Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist | Baseline, 5 weeks | |
| Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist | Baseline, 5 weeks | |
| Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist | Baseline, 5 weeks | |
| Change in symptoms of vaginal and vulvar atrophy and dryness: symptom questionnaires; scoring from 0 to 3 dryness, burning, itching; VAS evaluation of mucosal dryness, irritation, soreness, pain during exercise, pain during intercourse | Baseline, 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of vaginal and vulvar atrophy and dryness: symptom logbooks; daily scoring from 0 to 3 dryness, burning, itching, pain, soreness, symptoms during intercourse | From baseline to 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Risto Erkkola, Professor | Turun Gynekologikeskus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turun Gynekologikeskus | Turku | 20100 | Finland |
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| Device |
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