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

NCT ID: NCT03044652

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-06-30

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.

Conditions

Vulvovaginal Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical Device: WO2085 Moisturising Cream

WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.

Group Type: EXPERIMENTAL

WO2085 Moisturising Cream

Intervention Type: DEVICE

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).

Drug: Estriol Cream 0.1%

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

Group Type: ACTIVE_COMPARATOR

Estriol Cream 0.1%

Intervention Type: 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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

proDERM Institut für Angewandte Dermatologische Forschung GmbH

UNKNOWN

Sponsor Role: collaborator

Bremer Pharmacovigilance Service GmbH

OTHER

Sponsor Role: collaborator

GCP-Service International Ltd. & Co. KG

INDUSTRY

Sponsor Role: collaborator

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Christoph Abels, MD, PhD

Role: STUDY_DIRECTOR

Dr. August Wolff GmbH & Co. KG Arzneimittel

Prof. Petra Stute, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Frauenheilkunde, Inselspital Bern

Kirstin Deuble-Bente, MD

Role: PRINCIPAL_INVESTIGATOR

proDERM Institute for Applied Dermatological Research, Germany

Locations

Dr. Gerick

Aachen, , Germany

Praxis für die Frau

Mölln, , Germany

proDERM Institute for Applied Dermatological Research

Schenefeld, , Germany

Praxis für die Frau

Schwarzenbek, , Germany

Frauenklinik Inselspital Bern

Bern, , Switzerland

Countries

Germany; Switzerland

References

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

Reference Type: BACKGROUND

PMID: 8775770 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20196634 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25845406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23985562 (View on PubMed)

Other Identifiers

2016-002199-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VFCr-12/2015

Identifier Type: -

Identifier Source: org_study_id