Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol
Primary Purpose
Vulvovaginal Atrophy
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
WO2085 Moisturising Cream
Estriol Cream 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Vulvovaginal Dryness
Eligibility 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).
Sites / Locations
- Dr. Gerick
- Praxis für die Frau
- proDERM Institute for Applied Dermatological Research
- Praxis für die Frau
- Frauenklinik Inselspital Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medical Device: WO2085 Moisturising Cream
Drug: Estriol Cream 0.1%
Arm Description
WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
Estriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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.
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.
Adverse Events
Adverse events will be documented on Visits after 3 and 6 weeks, respectively (and in the patient diary, if applicable).
Full Information
NCT ID
NCT03044652
First Posted
December 21, 2016
Last Updated
July 11, 2017
Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
proDERM Institut für Angewandte Dermatologische Forschung GmbH, Bremer Pharmacovigilance Service GmbH, GCP-Service International Ltd. & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT03044652
Brief Title
Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
proDERM Institut für Angewandte Dermatologische Forschung GmbH, Bremer Pharmacovigilance Service GmbH, GCP-Service International Ltd. & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
"Vaginal dryness" is defined as dryness, itching, burning and pain unrelated to sexual intercourse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
Vulvovaginal Dryness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Device: WO2085 Moisturising Cream
Arm Type
Experimental
Arm Description
WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
Arm Title
Drug: Estriol Cream 0.1%
Arm Type
Active Comparator
Arm Description
Estriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women.
Intervention Type
Device
Intervention Name(s)
WO2085 Moisturising Cream
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Estriol Cream 0.1%
Intervention Description
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 Measure Information:
Title
Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks.
Description
"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.
Time Frame
Baseline, after 3 and 6 weeks
Secondary Outcome Measure Information:
Title
Overall impairment of daily life
Description
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)
Time Frame
6 weeks
Title
Global judgement of efficacy
Description
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.
Time Frame
6 weeks
Title
Global judgement of tolerability
Description
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.
Time Frame
6 weeks
Title
Adverse Events
Description
Adverse events will be documented on Visits after 3 and 6 weeks, respectively (and in the patient diary, if applicable).
Time Frame
after 3 and 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Christoph Abels, MD, PhD
Organizational Affiliation
Dr. August Wolff GmbH & Co. KG Arzneimittel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof. Petra Stute, MD, PhD
Organizational Affiliation
Universitätsklinik für Frauenheilkunde, Inselspital Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirstin Deuble-Bente, MD
Organizational Affiliation
proDERM Institute for Applied Dermatological Research, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Gerick
City
Aachen
Country
Germany
Facility Name
Praxis für die Frau
City
Mölln
Country
Germany
Facility Name
proDERM Institute for Applied Dermatological Research
City
Schenefeld
Country
Germany
Facility Name
Praxis für die Frau
City
Schwarzenbek
Country
Germany
Facility Name
Frauenklinik Inselspital Bern
City
Bern
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8775770
Citation
Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995 Dec;22 Suppl:S1-S5. doi: 10.1016/0378-5122(95)00956-6.
Results Reference
background
PubMed Identifier
20196634
Citation
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.
Results Reference
background
PubMed Identifier
25845406
Citation
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.
Results Reference
background
PubMed Identifier
23985562
Citation
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.
Results Reference
background
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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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