Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Petra Larmo225 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

225

Conditions

Vaginal Dryness Vaginal Atrophy Vulvar Dryness Vulvar Atrophy

Interventions

Moisturizing vaginal and vulvar sea buckthorn oil creamDEVICE

Moisturizing vaginal and vulvar creamDEVICE

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Turun Gynekologikeskus

Turku, Finland

Outcomes

Primary Outcomes

Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture

Time frame: Baseline, 5 weeks

Change in vaginal and vulvar pH

Time frame: Baseline, 5 weeks

Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist

Time frame: Baseline, 5 weeks

Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist

Time frame: Baseline, 5 weeks

Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist

Time frame: 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

Time frame: Baseline, 5 weeks

Secondary Outcomes

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

Time frame: From baseline to 5 weeks

Data from ClinicalTrials.gov

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