Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Not Applicable

Completed

• Conditions: Vulvar Dryness; Vaginal Dryness; Vaginal Atrophy; Vulvar Atrophy
• Interventions: Device: Moisturizing vaginal and vulvar sea buckthorn oil cream; Device: Moisturizing vaginal and vulvar cream

• Registration Number: NCT02937805
• Lead Sponsor: Petra Larmo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2017-07
• Study Completion: 2017-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moisturizing vaginal and vulvar sea buckthorn oil cream	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
Moisturizing vaginal and vulvar cream	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

Primary Outcome Measures

Name	Time	Method
Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist	Baseline, 5 weeks
Change in vaginal and vulvar pH	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
Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist	Baseline, 5 weeks
Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture	Baseline, 5 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Turun Gynekologikeskus; 🇫🇮 Turku, Finland