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

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ClinicalTrials.gov Identifier: NCT03044652
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
proDERM Institut für Angewandte Dermatologische Forschung GmbH
Bremer Pharmacovigilance Service GmbH
GCP-Service International Ltd. & Co. KG
Information provided by (Responsible Party):
Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief 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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Device: WO2085 Moisturising Cream Drug: Estriol Cream 0.1% Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Estriol

Arm Intervention/treatment
Experimental: Medical Device: WO2085 Moisturising Cream
WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
Device: WO2085 Moisturising Cream
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).

Active Comparator: Drug: Estriol Cream 0.1%
Estriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women.
Drug: Estriol Cream 0.1%
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.




Primary Outcome Measures :
  1. Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks. [ Time Frame: Baseline, after 3 and 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.


Secondary Outcome Measures :
  1. Overall impairment of daily life [ Time Frame: 6 weeks ]
    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)

  2. Global judgement of efficacy [ Time Frame: 6 weeks ]
    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.

  3. Global judgement of tolerability [ Time Frame: 6 weeks ]
    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.

  4. Adverse Events [ Time Frame: after 3 and 6 weeks ]
    Adverse events will be documented on Visits after 3 and 6 weeks, respectively (and in the patient diary, if applicable).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044652


Locations
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Germany
Dr. Gerick
Aachen, Germany
Praxis für die Frau
Mölln, Germany
proDERM Institute for Applied Dermatological Research
Schenefeld, Germany
Praxis für die Frau
Schwarzenbek, Germany
Switzerland
Frauenklinik Inselspital Bern
Bern, Switzerland
Sponsors and Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel
proDERM Institut für Angewandte Dermatologische Forschung GmbH
Bremer Pharmacovigilance Service GmbH
GCP-Service International Ltd. & Co. KG
Investigators
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Study Director: Prof. Christoph Abels, MD, PhD Dr. August Wolff GmbH & Co. KG Arzneimittel
Principal Investigator: Prof. Petra Stute, MD, PhD Universitätsklinik für Frauenheilkunde, Inselspital Bern
Principal Investigator: Kirstin Deuble-Bente, MD proDERM Institute for Applied Dermatological Research, Germany

Publications:
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Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier: NCT03044652    
Other Study ID Numbers: VFCr-12/2015
2016-002199-28 ( EudraCT Number )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. August Wolff GmbH & Co. KG Arzneimittel:
Vulvovaginal Dryness
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical