Skip to main content
OpenTrials
Completed

NCT Number: NCT03044652

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Gerick, Aachen, Germany

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • Bremer Pharmacovigilance Service GmbH
  • GCP-Service International Ltd. & Co. KG
  • proDERM Institut für Angewandte Dermatologische Forschung GmbH

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2017
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.