Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2017

Interventions

  • Device: Moisturizing vaginal and vulvar sea buckthorn oil cream
  • Device: Moisturizing vaginal and vulvar cream

Arms, Groups and Cohorts

  • Experimental: Moisturizing vaginal and vulvar sea buckthorn oil cream
    • 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
  • Active Comparator: Moisturizing vaginal and vulvar cream
    • 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
  • No Intervention: Control
    • No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Petra Larmo
  • Collaborator
    • Turun Gynekologikeskus Oy
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Petra Larmo, R&D Manager – Aromtech Ltd.
  • Overall Official(s)
    • Risto Erkkola, Professor, Principal Investigator, Turun Gynekologikeskus

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