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Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Primary Purpose

Vaginal Dryness, Vaginal Atrophy, Vulvar Dryness

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Moisturizing vaginal and vulvar sea buckthorn oil cream
Moisturizing vaginal and vulvar cream
Sponsored by
Petra Larmo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Dryness

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Turun Gynekologikeskus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Moisturizing vaginal and vulvar sea buckthorn oil cream

Moisturizing vaginal and vulvar cream

Control

Arm Description

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 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 moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55

Outcomes

Primary Outcome Measures

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

Secondary Outcome 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

Full Information

First Posted
October 11, 2016
Last Updated
June 29, 2018
Sponsor
Petra Larmo
Collaborators
Turun Gynekologikeskus Oy, Tekes - The Finnish Funding Agency for Technology and Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT02937805
Brief Title
Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Petra Larmo
Collaborators
Turun Gynekologikeskus Oy, Tekes - The Finnish Funding Agency for Technology and Innovation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Dryness, Vaginal Atrophy, Vulvar Dryness, Vulvar Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moisturizing vaginal and vulvar sea buckthorn oil cream
Arm Type
Experimental
Arm Description
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
Arm Title
Moisturizing vaginal and vulvar cream
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55
Intervention Type
Device
Intervention Name(s)
Moisturizing vaginal and vulvar sea buckthorn oil cream
Intervention Type
Device
Intervention Name(s)
Moisturizing vaginal and vulvar cream
Primary Outcome Measure Information:
Title
Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture
Time Frame
Baseline, 5 weeks
Title
Change in vaginal and vulvar pH
Time Frame
Baseline, 5 weeks
Title
Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist
Time Frame
Baseline, 5 weeks
Title
Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist
Time Frame
Baseline, 5 weeks
Title
Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist
Time Frame
Baseline, 5 weeks
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risto Erkkola, Professor
Organizational Affiliation
Turun Gynekologikeskus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turun Gynekologikeskus
City
Turku
ZIP/Postal Code
20100
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

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