Vulvovaginal AtrophyNCT03593122
Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness
A study testing WO2085 Moisturising Cream in people with Vulvovaginal Atrophy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 17 sites in Germany.
Trial summary
The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- WO2085 Moisturising Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 17 sitesGermany
- Study dates
- 4 Jan 2010to 31 Jul 2010
- 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 with breast cancer undergoing chemotherapy OR therapy with aromatase inhibitors or anti-oestrogens (either at present or up to 3 months after ending treatment) AND with symptoms of vulvovaginal dryness since the start of tumour treatment
- Written declaration of consent for the voluntary participation in the study is present
Who cannot join
- Women who suffered symptoms of vulvovaginal dryness prior to the start of tumour treatment
- Patients undergoing radiation therapy
- Patients with other tumours
- A current vaginal infection
- Medical conditions related to the vulva or vagina
- Current additional therapy of vulvovaginal dryness or vulvovaginal atrophy
Show all 9Show fewer
- Women who are not able to participate properly in this study
- Current alcohol and/or drug abuse
- Pregnant or lactating women
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
Axel Gerick
Aachen, 52072
Sibylle Kaßpohl
Alzenau in Unterfranken, 63755
Jörg Schilling
Berlin, 10317
Axel Widing
Berlin, 12107
Alexandra Coumbos
Berlin, 12167
Amin Mortazawi
Darmstadt, 64287
Kathrin von Ardenne
Dresden, 01326
Joachim Larbig
Fulda, 36037
Nidal Gazawi
Leipzig, 04107
Elke Wierick
Lohsa, 02999
Dagmar Guth
Plauen, 08525
Wolfgang Clemens
Stolberg, 52222
Carsten Hielscher
Stralsund, 18435
Christopher Wolf
Ulm, 89073
Heidi Massinger-Biebl
Waldkirchen, 94065
Klaus Doubek
Wiesbaden, 65185
Anja Obermeyer
Würselen
About this study
Official title: Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness
The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors
Read the detailed description
The goal of this application study was to answer the question as to whether the application of WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors can result in an improvement in the subjective symptoms and objective diagnoses of vulvovaginal dryness while also ensuring good tolerability.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- WO2085 Moisturising Cream
- Keywords
- Vulvovaginal Dryness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WO2085 Moisturising CreamDevice
Week 1: 2.5 g of the investigational product WO2085 Moisturising Cream will be applied intravaginally, once daily in the evening. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day).
Week 2-4: The frequency may be reduced by the patient as needed. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day).
| Study group | Role | What they receive |
|---|---|---|
| WO 2085 Moisturising Cream | Experimental | WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms. Receives: Device: WO2085 Moisturising Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)
Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced)
Measured: Baseline, after 4 weeks
Secondary outcomes (4)
Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)
Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced)
Measured: 4 weeks
Global judgement of efficacy
The global judgement of efficacy will be assessed by the investigator and the patient according to the following scale: 1=very good to 6=unsatisfactory.
Measured: 4 weeks
Global judgement of tolerability
The global judgement of tolerability will be assessed by the investigator and the patient according to the following scale: 1=very good to 6=unsatisfactory.
Measured: 4 weeks
Adverse Events
Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start4 Jan 2010
- Primary completion31 Jul 2010
- Study completion31 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal AtrophyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Dimitrios Chatsiproios, Dr. med. Klaus König, SAM®, Statistische Analysen und Monitoring GmbH
- Responsible party
- Sponsor
- Investigators
- Prof. Christoph Abels, MD, PhD, Study director, Dr. August Wolff GmbH & Co. KG Arzneimittel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593122
- Sponsor's protocol ID
- VFAU-13/2009
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness
- ClinicalTrials.gov ID
- NCT03593122
- Acronym / sponsor ID
- VFAU-13/2009
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Vulvovaginal Dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Dimitrios Chatsiproios, Dr. med. Klaus König, SAM®, Statistische Analysen und Monitoring GmbH
- Study start
- 4 Jan 2010 (actual)
- Primary completion
- 31 Jul 2010 (actual)
- Study completion
- 31 Jul 2010 (actual)
- First posted
- 19 Jul 2018 (actual)
- 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.
The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors
Detailed description
The goal of this application study was to answer the question as to whether the application of WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors can result in an improvement in the subjective symptoms and objective diagnoses of vulvovaginal dryness while also ensuring good tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WO 2085 Moisturising Cream | Experimental | Device: WO2085 Moisturising CreamWO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with breast cancer undergoing chemotherapy OR therapy with aromatase inhibitors or anti-oestrogens (either at present or up to 3 months after ending treatment) AND with symptoms of vulvovaginal dryness since the start of tumour treatment
- Written declaration of consent for the voluntary participation in the study is present
Key exclusion criteria (9 listed)
- Women who suffered symptoms of vulvovaginal dryness prior to the start of tumour treatment
- Patients undergoing radiation therapy
- Patients with other tumours
- A current vaginal infection
- Medical conditions related to the vulva or vagina
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 |
|---|---|---|
| WO2085 Moisturising CreamWeek 1: 2.5 g of the investigational product WO2085 Moisturising Cream will be applied intravaginally, once daily in the evening. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day). Week 2-4: The frequency may be reduced by the patient as needed. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day). | Device | WO 2085 Moisturising Cream |
Primary outcome
Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)
Time frame: Baseline, after 4 weeks
Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced)
4 secondary outcomes
Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)
Time frame: 4 weeks
Global judgement of efficacy
Time frame: 4 weeks
Global judgement of tolerability
Time frame: 4 weeks
Adverse Events
Time frame: after 4 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 19 Jul 2018.
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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.
Prof. Christoph Abels, MD, PhD study director
Dr. August Wolff GmbH & Co. KG Arzneimittel
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WO2085 Moisturising Cream in people with Vulvovaginal Atrophy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 17 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 2 inclusion and 9 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 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 17 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?
Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching) (time frame: Baseline, after 4 weeks). 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 19 Jul 2018.