Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Study Overview
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Brief Summary
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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.

Conditions
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Vaginal Dryness, Vaginal Atrophy, Vulvar Dryness, Vulvar Atrophy

Intervention / Treatment
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* Device: Moisturizing vaginal and vulvar sea buckthorn oil cream
* Device: Moisturizing vaginal and vulvar cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of vaginal dryness, burning or itching Symptom severity at least moderate Exclusion Criteria: Systemic hormonal replacement therapy during the last 12 months Local hormonal replacement therapy during the last 4 weeks Known allergy to ingredients of the study creams Pregnancy Breast-feeding

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moisturizing vaginal and vulvar sea buckthorn oil cream<br>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 | Device: Moisturizing vaginal and vulvar sea buckthorn oil cream<br> <br> |
| Active Comparator: Moisturizing vaginal and vulvar cream<br>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 | Device: Moisturizing vaginal and vulvar cream<br> <br> |
| No Intervention: Control<br>No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |