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Vulvovaginal AtrophyPhase 4NCT03044652

Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol

A Phase 4 study testing WO2085 Moisturising Cream and Estriol Cream 0.1% in people with Vulvovaginal Atrophy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol. 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 and Estriol Cream 0.1%
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
5 sitesin 2 countries
Study dates
Nov 2016to Jun 2017
Phase
Phase 4
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

  • Post-menopausal women with the subjective symptoms of "vulvovaginal dryness" with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VAS value "Overall impairment of daily life due to the condition "vulvovaginal dryness" > 0 on Visit 1.
  • Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit 1.
  • Physical and mental healthy women as assessed by the medical history.
  • PAP test performed within the last 12 months before Visit 1 and result less than PAP III.
  • Signed written informed consent before participation in the Trial.
  • Willingness to actively participate in the trial and to come to the scheduled visits.

Who cannot join

  • Known hypersensitivity against any of the ingredients of the test products.
  • Any indication in the medical history regarding an impairment of the hepatic, renal, gastrointestinal, cardiovascular, pulmonary, endocrinological or hematological system (especially venous and arterial thromboembolism, ischemic stroke, myocardial infarction, porphyria) if clinically relevant for this clinical trial (cf. contraindications and warnings for Estriol cream 0.1%).
  • Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency).
  • Breast cancer (acute and / or in the medical history or suspected).
  • Estrogen-dependent tumor (acute and / or in the medical history or suspected, especially ovarian and / or endometrial carcinoma).
  • Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (inter alia anti-estrogens) within 3 months before Visit 1 and / or during the conduct of this trial.
Show all 10Show fewer
  • Intrauterine device (IUD) with progestogen (Mirena®, Jaydess®)
  • Pathological findings in cancer screening (Papanicolaou III, III D - V in the cervical test)
  • Pathological changes in the vaginal or cervix area, which are caused by estrogen deficiency (except symptoms and condition of "vulvovaginal dryness"), e.g. diminution of labia caused by estrogen deficiency, constricted introitus.
  • Patients with known infectious diseases (e.g. hepatitis or HIV infection).

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany4 sites

  • Dr. Gerick

    Aachen

  • Praxis für die Frau

    Mölln

  • proDERM Institute for Applied Dermatological Research

    Schenefeld

  • Praxis für die Frau

    Schwarzenbek

Other trials in Germany

Switzerland1 site

  • Frauenklinik Inselspital Bern

    Bern

Other trials in Switzerland

About this study

Official title: Prospective, Open-label, Multicenter, Multinational, Randomized Trial to Investigate the Non-inferiority of Treatment With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol in a Panel of Post-menopausal Women Suffering From the Symptoms of Vulvovaginal Dryness in a Parallel Group Design

The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol.

Read the detailed description

"Vaginal dryness" is defined as dryness, itching, burning and pain unrelated to sexual intercourse.

Being tested
WO2085 Moisturising Cream, Estriol Cream 0.1%
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

    2.5 g of the investigational product WO2085 Moisturising Cream will be applied intravaginally, once daily in the evening. After improvement of the symptoms 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).

  • Estriol Cream 0.1%Drug

    0.5 g of the reference product Estriol Cream 0.1% will be applied intravaginally once daily in the evening for the first 3 weeks. Subsequently, the frequency will be reduced to twice a week for the last 3 weeks for all patients in this treatment group.

Study groups in NCT03044652
Study groupRoleWhat they receive
Medical Device: WO2085 Moisturising CreamExperimentalWO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
Receives: Device: WO2085 Moisturising Cream
Drug: Estriol Cream 0.1%Active comparatorEstriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women.
Receives: Drug: Estriol Cream 0.1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks.

    "Vulvovaginal dryness" will be measured by the Total Severity Score. It is defined as the sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse, each scored from 0=none to 4=very severe. In total a range of 0=no complaints to 16=very severe complaints is possible. Differences to Baseline (Visit 1) of the Total Severity Score assessed after six weeks of treatment (Visit 3) serve as the primary endpoint for the test of non-inferiority.

    Measured: Baseline, after 3 and 6 weeks

Secondary outcomes (4)

  1. Overall impairment of daily life

    Overall impairment of daily life due to the condition "vaginal dryness" (including subgroup analysis of patients with mild, moderate or severe impairment) will be measured by using a Visual Analogue Scale (VAS)

    Measured: 6 weeks

  2. 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 4=poor.

    Measured: 6 weeks

  3. 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 4=poor.

    Measured: 6 weeks

  4. Adverse Events

    Adverse events will be documented on Visits after 3 and 6 weeks, respectively (and in the patient diary, if applicable).

    Measured: after 3 and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2017 (estimated)
  2. Study startNov 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03044652
Sponsor's protocol ID
VFCr-12/2015
Other IDs
2016-002199-28, 2016
Status last verified
Jul 2017
First submitted
21 Dec 2016
Last updated
14 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995 Dec;22 Suppl:S1-S5. doi: 10.1016/0378-5122(95)00956-6.

    PubMed 8775770

  • Biglia N, Peano E, Sgandurra P, Moggio G, Panuccio E, Migliardi M, Ravarino N, Ponzone R, Sismondi P. Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. Gynecol Endocrinol. 2010 Jun;26(6):404-12. doi: 10.3109/09513591003632258.

    PubMed 20196634

  • 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

  • Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.

    PubMed 23985562

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing WO2085 Moisturising Cream and Estriol Cream 0.1% in people with Vulvovaginal Atrophy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 5 sites in 2 countries.

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 6 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 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Switzerland. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks. (time frame: Baseline, after 3 and 6 weeks). 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 NCT03044652, which also lists 4 linked publications.

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 14 Jul 2017.

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