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NCT02937805 Clinical Trial

Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Vaginal Atrophy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02937805
Other study ID # MCMM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date September 2017

Study information
Verified date June 2018
Source Aromtech Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date September 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Moisturizing vaginal and vulvar sea buckthorn oil cream

• Moisturizing vaginal and vulvar cream

Locations
Country Name City State
Finland Turun Gynekologikeskus Turku

Sponsors (3)
Lead Sponsor Collaborator
Petra Larmo Tekes - The Finnish Funding Agency for Technology and Innovation, Turun Gynekologikeskus Oy

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture Baseline, 5 weeks
Primary Change in vaginal and vulvar pH Baseline, 5 weeks
Primary Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist Baseline, 5 weeks
Primary Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist Baseline, 5 weeks
Primary Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist Baseline, 5 weeks
Primary 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 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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