Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

June 29, 2018 updated by: Petra Larmo
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20100
        • Turun Gynekologikeskus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Moisturizing vaginal and vulvar sea buckthorn oil cream
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
Device: Moisturizing vaginal and vulvar cream
No Intervention: Control
No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: From baseline to 5 weeks
From baseline to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petra Larmo

Collaborators

Turun Gynekologikeskus Oy
Tekes - The Finnish Funding Agency for Technology and Innovation

Investigators

  • Principal Investigator: Risto Erkkola, Professor, Turun Gynekologikeskus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCMM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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