Vaginal DrynessNCT02269826
Efficacy and Safety of Non-hormonal Vaginal Preparations in Treating Vaginal Dryness
A study testing Vagisan® Moisturising Cream and Gynomunal® vaginal gel in people with Vaginal Dryness, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 6 sites in Germany.
Trial summary
Vulvovaginal irritation due to dryness is a frequent complaint among post- and some premenopausal women. International guidelines recommend non-hormonal products as first line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Dryness
- What is being tested?
- Vagisan® Moisturising Cream and Gynomunal® vaginal gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 6 sitesGermany
- Study dates
- Feb 2008to Dec 2008
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over the age of 18.
- Women with vaginal dryness who do not want to or are not allowed to use oestrogens, such as post-menopausal women, women with oestrogen-dependent tumours in their medical history and women who had been treated with systemic medicinal products that can have a drying-out effect on the vaginal mucous membranes.
- Total score (0-16) of at least 3 of four subjective symptoms (feeling of dryness, itching, burning sensation and pain).
- Written declaration of consent for the voluntary participation in the study is present.
Who cannot join
- Known hypersensitivity to one of the ingredients of the test and/or reference medical device.
- Current vaginal infections.
- Recurring (i.e. at least 3) vaginal infections within the last 12 months.
- Additional (not study-related) treatment of vaginal dryness during the therapy phases.
- Therapy with antibiotics, steroids (excluding sexual steroids in oral, dermal or transdermal application) or antimycotics in the last 14 days before inclusion and participation in this study.
- Women who are not able to participate properly in this study.
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- Fertile women without sufficient contraceptive protection.
- Fertile women who are pregnant (positive HCG test) or breastfeeding.
- Current alcohol and/or drug abuse.
- Participation in another clinical study within the last four weeks and/or parallel participation in this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Dr. med. Kirsten Grunwald
Aachen, 52064
Dr. med. Julia Wanke
Aachen, 52070
Dr. med. Axel Gerick
Aachen, 52072
Dr. med. Ralf Conrads
Aachen, 52078
Wolfgang Clemens
Stolberg, 52222
Anja Obermeyer
Würselen, 52146
About this study
Official title: Medical Device Study to Investigate the Efficacy and Tolerability of Vagisan® Moisturising Cream vs. Gynomunal® Vaginal Gel in a 2-period Changeover Design in n=120 Patients With Vaginal Dryness Who Cannot or do Not Wish to Use Oestrogens
Vulvovaginal irritation due to dryness is a frequent complaint among post- and some premenopausal women. International guidelines recommend non-hormonal products as first line therapy.
Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised, two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.
The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects were planned to be assessed. 120 women should be randomly allocated to either of the two treatments, each given over a period of 4 weeks.
Read the detailed description
The purpose of the study was to test the non-inferiority of the medical device Vagisan® Moisturising Cream (VMC) in comparison to Gynomunal® vaginal gel (GVG) in 6 centres in 120 women who suffered from "vaginal dryness". The main objective criterion was to compare the sum of 4 subjective symptoms of "vaginal dryness" measured daily over a period of 28 days. VMC should be applied daily, while GVG had to be administered daily during the first week and twice weekly thereafter.
The main objective parameter for efficacy analysis was the sum of the subjective symptoms of vaginal dryness (feeling of dryness, itching, burning sensation and pain) before, during (patient diaries) and after the 28-day therapy period.
The per-protocol analysis and of the intent-to-treat analysis should prove non-inferiority of VMC compared to GVG, despite a possible carry-over effect to the detriment of VMC. To avoid the problem of any possible carry-over effect the analysis of the first period was chosen for the primary comparison of both products.
Furthermore, objective symptoms of vaginal dryness detected via colposcopy, the vaginal secretion's pH, the efficacy assessment by the patients and the treating doctor and patients' questionnaires with regard to the product characteristics of the medical devices should be evaluated.
- Conditions
- Vaginal Dryness
- Being tested
- Vagisan® Moisturising Cream, Gynomunal® vaginal gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagisan® Moisturising CreamDevice
Also called WO 2085
Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).
Gynomunal® vaginal gelDevice
Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).
| Study group | Role | What they receive |
|---|---|---|
| Vagisan® Moisturising Cream | Experimental | non-hormonal vaginal cream for the treatment of vulvovaginal dryness Receives: Device: Vagisan® Moisturising Cream |
| Gynomunal® vaginal gel | Active comparator | non-hormonal gel Receives: Device: Gynomunal® vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain)
The main objective criterion for the confirmatory analysis was the per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced) during the course of therapy. This was based on the daily entry in the patient diary.
Measured: Therapy period of 28 days
Secondary outcomes (7)
Intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses
- Descriptive account of the per patient intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses made by the investigator during the visits (thinning of the epithelium, redness, petechial bleeding, discharge, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced).
Measured: 28 days
Patients' individual subjective symptoms of "vaginal dryness"
Descriptive account of the patients' individual subjective symptoms of "vaginal dryness" expressed during the visits (feeling of dryness, itching, burning sensation and pain).
Measured: 28 days
Overall efficacy and tolerability assessments
The overall efficacy and tolerability assessments (investigator and/or patient) with the ratings "very good", "good", "satisfactory" and "poor".
Measured: 28 days
Occurrence of side effects
The assessment of one-sided 95% confidence intervals for the occurrence of side effects when using the test and reference medical device
Measured: 28 days
Assessment of adverse events
The assessment of adverse events that have not been classified as related to the medical device.
Measured: 28 days
Vaginal pH
Descriptive account of the vaginal pH as determined by the investigator during the visits.
Measured: 28 days
Patients' subjective satisfaction with the test and reference medical device
The patients' subjective satisfaction with the test and reference medical device based on a patient questionnaire conducted at the end of each treatment period [feeling of skin (within approximately 10 minutes of application and the following morning), discharge the next morning, stickiness, spreadability on the vulva (perivaginal), cooling effect, softness of the medical device, fragrance, handling of the applicator, overall assessment by the sexual partner] with ratings from 1 (very positive) to 6 (very negative) or 0=no assessment (see chapter 9.1.6 "Patient questionnaire").
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Abels, Prof., MD, Study director, Dr. August Wolff GmbH & Co. KG ArzneimittelKlaus-Michael Grunwald, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269826
- Sponsor's protocol ID
- LB-04/2007
- Status last verified
- Feb 2018
- First submitted
- 14 Oct 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stute P, May TW, Masur C, Schmidts-Winkler IM. Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. Climacteric. 2015;18(4):582-9. doi: 10.3109/13697137.2015.1036854. Epub 2015 May 22.
PubMed 25845406
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Device Study to Investigate the Efficacy and Tolerability of Vagisan® Moisturising Cream vs. Gynomunal® Vaginal Gel in a 2-period Changeover Design in n=120 Patients With Vaginal Dryness Who Cannot or do Not Wish to Use Oestrogens
- ClinicalTrials.gov ID
- NCT02269826
- Acronym / sponsor ID
- LB-04/2007
- Conditions
- Vaginal Dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Oct 2014 (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 irritation due to dryness is a frequent complaint among post- and some premenopausal women. International guidelines recommend non-hormonal products as first line therapy.
Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised, two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.
The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects were planned to be assessed. 120 women should be randomly allocated to either of the two treatments, each given over a period of 4 weeks.
Detailed description
The purpose of the study was to test the non-inferiority of the medical device Vagisan® Moisturising Cream (VMC) in comparison to Gynomunal® vaginal gel (GVG) in 6 centres in 120 women who suffered from "vaginal dryness". The main objective criterion was to compare the sum of 4 subjective symptoms of "vaginal dryness" measured daily over a period of 28 days. VMC should be applied daily, while GVG had to be administered daily during the first week and twice weekly thereafter.
The main objective parameter for efficacy analysis was the sum of the subjective symptoms of vaginal dryness (feeling of dryness, itching, burning sensation and pain) before, during (patient diaries) and after the 28-day therapy period.
The per-protocol analysis and of the intent-to-treat analysis should prove non-inferiority of VMC compared to GVG, despite a possible carry-over effect to the detriment of VMC. To avoid the problem of any possible carry-over effect the analysis of the first period was chosen for the primary comparison of both products.
Furthermore, objective symptoms of vaginal dryness detected via colposcopy, the vaginal secretion's pH, the efficacy assessment by the patients and the treating doctor and patients' questionnaires with regard to the product characteristics of the medical devices should be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagisan® Moisturising Cream | Experimental | Device: Vagisan® Moisturising Creamnon-hormonal vaginal cream for the treatment of vulvovaginal dryness |
| Gynomunal® vaginal gel | Active comparator | Device: Gynomunal® vaginal gelnon-hormonal gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women over the age of 18.
- Women with vaginal dryness who do not want to or are not allowed to use oestrogens, such as post-menopausal women, women with oestrogen-dependent tumours in their medical history and women who had been treated with systemic medicinal products that can have a drying-out effect on the vaginal mucous membranes.
- Total score (0-16) of at least 3 of four subjective symptoms (feeling of dryness, itching, burning sensation and pain).
- Written declaration of consent for the voluntary participation in the study is present.
Key exclusion criteria (10 listed)
- Known hypersensitivity to one of the ingredients of the test and/or reference medical device.
- Current vaginal infections.
- Recurring (i.e. at least 3) vaginal infections within the last 12 months.
- Additional (not study-related) treatment of vaginal dryness during the therapy phases.
- Therapy with antibiotics, steroids (excluding sexual steroids in oral, dermal or transdermal application) or antimycotics in the last 14 days before inclusion and participation in this study.
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 |
|---|---|---|
| Vagisan® Moisturising CreamAlso: WO 2085Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application). | Device | Vagisan® Moisturising Cream |
| Gynomunal® vaginal gelOnce in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application). | Device | Gynomunal® vaginal gel |
Primary outcome
per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain)
Time frame: Therapy period of 28 days
The main objective criterion for the confirmatory analysis was the per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced) during the course of therapy. This was based on the daily entry in the patient diary.
7 secondary outcomes
Intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses
Time frame: 28 days
Patients' individual subjective symptoms of "vaginal dryness"
Time frame: 28 days
Overall efficacy and tolerability assessments
Time frame: 28 days
Occurrence of side effects
Time frame: 28 days
Assessment of adverse events
Time frame: 28 days
Vaginal pH
Time frame: 28 days
Patients' subjective satisfaction with the test and reference medical device
Time frame: 28 days
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 19 Feb 2018.
- Derived from this study: PubMed 25845406Stute P, May TW, Masur C, Schmidts-Winkler IM. Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. Climacteric. 2015;18(4):582-9. doi: 10.3109/13697137.2015.1036854. Epub 2015 May 22.
- 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.
Christoph Abels, Prof., MD study director
Dr. August Wolff GmbH & Co. KG Arzneimittel
Klaus-Michael Grunwald, MD principal investigator
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagisan® Moisturising Cream and Gynomunal® vaginal gel in people with Vaginal Dryness, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 6 sites in Germany.
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 4 inclusion and 10 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain) (time frame: Therapy period of 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269826, which also lists 1 linked publication.
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 19 Feb 2018.