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

NCT03044652 | Completed Phase 4

• 2 other identifiers: VFCr-12/20152016-002199-28
• Study Type: interventional
• Target: 172
• Locations: 2 countries
• Sites: 5

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.

Conditions

Vulvovaginal Atrophy

Keywords

Vulvovaginal Dryness

Outcome Measures

Primary Outcomes (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.

  Baseline, after 3 and 6 weeks

Secondary Outcomes (4)

• Overall impairment of daily life

  6 weeks

• Global judgement of efficacy

  6 weeks

• Global judgement of tolerability

  6 weeks

• Adverse Events

  after 3 and 6 weeks

Study Arms (2)

Medical Device: WO2085 Moisturising Cream

EXPERIMENTAL

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

Device: WO2085 Moisturising Cream

Drug: Estriol Cream 0.1%

ACTIVE COMPARATOR

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

Drug: Estriol Cream 0.1%

Interventions

WO2085 Moisturising Cream 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).

Medical Device: WO2085 Moisturising Cream

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.

Drug: Estriol Cream 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead
• proDERM Institut für Angewandte Dermatologische Forschung GmbH: collaborator
• Bremer Pharmacovigilance Service GmbH: collaborator
• GCP-Service International Ltd. & Co. KG: collaborator

Study Sites (5)

Dr. Gerick

Aachen, Germany

Location

Praxis für die Frau

Mölln, Germany

Location

proDERM Institute for Applied Dermatological Research

Schenefeld, Germany

Location

Praxis für die Frau

Schwarzenbek, Germany

Location

Frauenklinik Inselspital Bern

Bern, Switzerland

Location

Related Publications (4)

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

  PMID: 8775770 BACKGROUND

• 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.

  PMID: 20196634 BACKGROUND

• 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.

  PMID: 25845406 BACKGROUND

• 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.

  PMID: 23985562 BACKGROUND

Study Officials

• Prof. Christoph Abels, MD, PhD

  Dr. August Wolff GmbH & Co. KG Arzneimittel

  STUDY DIRECTOR

• Prof. Petra Stute, MD, PhD

  Universitätsklinik für Frauenheilkunde, Inselspital Bern

  PRINCIPAL INVESTIGATOR

• Kirstin Deuble-Bente, MD

  proDERM Institute for Applied Dermatological Research, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: February 7, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); CH (1)