Vaginal DrynessNCT02937805
Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
A study testing Moisturizing vaginal and vulvar sea buckthorn oil cream and Moisturizing vaginal and vulvar cream in people with Vaginal Dryness and Vaginal Atrophy, run by Petra Larmo at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Dryness, Vaginal Atrophy, Vulvar Dryness
- What is being tested?
- Moisturizing vaginal and vulvar sea buckthorn oil cream and Moisturizing vaginal and vulvar cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptoms of vaginal dryness, burning or itching
- Symptom severity at least moderate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vaginal Dryness, Vaginal Atrophy, Vulvar Dryness, Vulvar Atrophy
- Being tested
- Moisturizing vaginal and vulvar sea buckthorn oil cream, Moisturizing vaginal and vulvar cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizing vaginal and vulvar sea buckthorn oil creamDevice
Moisturizing vaginal and vulvar creamDevice
| Study group | Role | What they receive |
|---|---|---|
| Moisturizing vaginal and vulvar sea buckthorn oil cream | Experimental | 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 Receives: Device: Moisturizing vaginal and vulvar sea buckthorn oil cream |
| Moisturizing vaginal and vulvar cream | Active comparator | 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 Receives: Device: Moisturizing vaginal and vulvar cream |
| Control | No intervention | No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture
Measured: Baseline, 5 weeks
Change in vaginal and vulvar pH
Measured: Baseline, 5 weeks
Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist
Measured: Baseline, 5 weeks
Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist
Measured: Baseline, 5 weeks
Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist
Measured: 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
Measured: Baseline, 5 weeks
Secondary outcomes (1)
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
Measured: From baseline to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DrynessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petra Larmo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Turun Gynekologikeskus Oy, The Finnish Funding Agency for Technology and Innovation
- Responsible party
- Sponsor-investigator, Petra Larmo, Aromtech Ltd.
- Investigators
- Risto Erkkola, Professor, Principal investigator, Turun Gynekologikeskus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937805
- Sponsor's protocol ID
- MCMM
- Status last verified
- Jun 2018
- First submitted
- 11 Oct 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
- ClinicalTrials.gov ID
- NCT02937805
- Acronym / sponsor ID
- MCMM
- Conditions
- Vaginal Dryness, Vaginal Atrophy, Vulvar Dryness, Vulvar Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Petra LarmoIndustry (pharma, biotech, devices)
- Collaborators
- Turun Gynekologikeskus Oy, The Finnish Funding Agency for Technology and Innovation
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moisturizing vaginal and vulvar sea buckthorn oil cream | Experimental | Device: Moisturizing vaginal and vulvar sea buckthorn oil creamMoisturizing 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 | Active comparator | Device: Moisturizing vaginal and vulvar creamMoisturizing 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 |
| Control | No intervention | –No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55 |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptoms of vaginal dryness, burning or itching
- Symptom severity at least moderate
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moisturizing vaginal and vulvar sea buckthorn oil cream | Device | Moisturizing vaginal and vulvar sea buckthorn oil cream |
| Moisturizing vaginal and vulvar cream | Device | Moisturizing vaginal and vulvar cream |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risto Erkkola, Professor principal investigator
Turun Gynekologikeskus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturizing vaginal and vulvar sea buckthorn oil cream and Moisturizing vaginal and vulvar cream in people with Vaginal Dryness and Vaginal Atrophy, run by Petra Larmo at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture (time frame: Baseline, 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.