Investigation of non-inferiority of treatment of "vulvovaginal dryness" with Vagisan® Moisturising Cream in comparison to an Estriol containing cream

Prospective, open-label, multicenter, multinational, randomized trial to investigate the non-inferiority of treatment with Vagisan® Moisturising Cream in comparison to an Estriol containing cream in a panel of post-menopausal women suffering from the symptoms of "vulvovaginal dryness" in a parallel group design

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002199-28-DE

Enrollment

172

Registered

2016-09-07

Start date

2016-10-11

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postmenopausal women suffering from symptoms of vulvovaginal dryness MedDRA version: 19.0 Level: PT Classification code 10047791 Term: Vulvovaginal dryness System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Ovestin 1 mg Creme Product Name: Ovestin 1 mg Creme Pharmaceutical Form: Cream INN or Proposed INN: ESTRIOL Other descriptiv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Post-menopausal women with the subjective symptomatology 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 86

Exclusion criteria

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 Ovestin®). •Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency). •Any indication of other significant acute or chronic impairments which may have an impact either on the safety of the patient or on the resorption, distribution, metabolism or the excretion of estriol. •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®) •Untreated endometrial hyperplasia •Undiagnosed vaginal bleeding. •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. •Local hormonal therapy (vagina/vulva) within 3 months before Visit 1 (also when used for the brightening/pretreatment of cytological smears). •Non-healed vaginal surgery. •Vaginal inflammation which is not caused by "vulvovaginal dryness". •Use of moisturizers (vagina/vulva) within 14 day before Visit 1 and during the conduct of this trial. •Any use of products (including lubricants), other than the test products, applied intravaginally or on the vulva during the conduct of this trial (except for the use of Vagisan® Intimwaschlotion, Note: should not be used, if allergic to chamomile). •Systemic corticosteroids within 14 days before Visit 1 and during the conduct of this trial (corticoid asthma sprays are allowed). •Chronic disease of the genital area, e.g. lichen sclerosus. •Patients with known infectious diseases (e.g. hepatitis or HIV infection). •Clinically diagnosed vaginal infection (acute or during the conduct of the trial). •Use of antibiotics or antimycotics within 14 days before Visit 1 and / or during this trial. •Body Mass Index 35 kg/m2. •Acute drug- or alcohol abuse. •Patients with poor compliance and / or poor willingness to cooperate. •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing. •Patients, who are inmates of psychiatric

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this trial is to investigate the non-inferiority of the treatment of "vulvovaginal dryness" with Vagisan® Moisturising Cream in comparison to an Estriol containing cream. The comparison will be based on the subjective assessment of the symptoms of "vulvovaginal dryness" (Total Severity Score: sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse). ; Secondary Objective: •Severity scoring for each of the subjective symptoms •Impairment of daily life due to each subjective symptom •Mean sum score for severity of the subjective symptoms and impairment of daily life •Severity scoring for dyspareunia •Impairment of daily life due to dyspareunia •Overall impairment of daily life due to the condition “vaginal dryness”, including subgroup analysis of patients with mild, moderate or severe impairment •Vaginal Health Index •Comparison of Vagisan® Moisturising Cream to Estriol containing cream on (AUC) over the course of the study for all above given parameters. •Vaginal status of Lactobacillus flora •Global judgement of efficacy by the Investigator/patient •Global judgement of tolerability by the Investigator/patient •Safety parameters •Pre-treatment of "vulvovaginal dryness" and satisfaction with the respective product •Urinary incontinence •Questionnaire about satisfaction •Dose and frequency of the treatment ; Primary end point(s): The Total Severity Score is defined as the sum of the single 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 complaint	—

Measure

Time frame

Main Objective: The main objective of this trial is to investigate the non-inferiority of the treatment of "vulvovaginal dryness" with Vagisan® Moisturising Cream in comparison to an Estriol containing cream. The comparison will be based on the subjective assessment of the symptoms of "vulvovaginal dryness" (Total Severity Score: sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse). ; Secondary Objective: •Severity scoring for each of the subjective symptoms •Impairment of daily life due to each subjective symptom •Mean sum score for severity of the subjective symptoms and impairment of daily life •Severity scoring for dyspareunia •Impairment of daily life due to dyspareunia •Overall impairment of daily life due to the condition “vaginal dryness”, including subgroup analysis of patients with mild, moderate or severe impairment •Vaginal Health Index •Comparison of Vagisan® Moisturising Cream to Estriol containing cream on (AUC) over the course of the study for all above given parameters. •Vaginal status of Lactobacillus flora •Global judgement of efficacy by the Investigator/patient •Global judgement of tolerability by the Investigator/patient •Safety parameters •Pre-treatment of "vulvovaginal dryness" and satisfaction with the respective product •Urinary incontinence •Questionnaire about satisfaction •Dose and frequency of the treatment ; Primary end point(s): The Total Severity Score is defined as the sum of the single 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 complaint

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Secondary

Measure	Time frame
Secondary end point(s): •Severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) at each visit and once weekly •AUC for severity scoring for each of the subjective symptoms over all assessment time points (at each visit and once weekly) •Impairment of daily life due to each subjective symptom at each visit and once weekly •AUC for impairment of daily life due to each subjective symptom over all assessment time points (at each visit and once weekly) •Mean sum score for severity of the subjective symptoms and impairment of daily life due to each subjective symptom at each visit and once weekly. For better interpretation severity scoring will be recalculated to a scale from 0 to 10 resulting in: mean sum score = (severity scoring + impairment of daily life) / 8 •AUC for this mean sum score over all assessment time points (at each visit and once weekly) •Severity scoring for dyspareunia (if sexually active) at each visit •AUC for severity scoring for dyspareunia (if sexually active) over all assessment time points (at each visit) •Impairment of daily life due to dyspareunia (if sexually active) at each visit •AUC for impairment of daily life due to dyspareunia (if sexually active) over all assessment time points (at each visit) •Overall impairment of daily life due to the condition “vaginal dryness”, including a subgroup analysis of patients with mild, moderate and severe overall impairment at each visit •AUC for overall impairment of daily life over all assessment time points (at each visit) •Vaginal Health Index, for each parameter, and as sum score over objective assessment of vaginal findings at each visit •AUC for Vaginal Health Index (for each parameter, and as sum score) over all	—

Measure

Time frame

Secondary end point(s): •Severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) at each visit and once weekly •AUC for severity scoring for each of the subjective symptoms over all assessment time points (at each visit and once weekly) •Impairment of daily life due to each subjective symptom at each visit and once weekly •AUC for impairment of daily life due to each subjective symptom over all assessment time points (at each visit and once weekly) •Mean sum score for severity of the subjective symptoms and impairment of daily life due to each subjective symptom at each visit and once weekly. For better interpretation severity scoring will be recalculated to a scale from 0 to 10 resulting in: mean sum score = (severity scoring + impairment of daily life) / 8 •AUC for this mean sum score over all assessment time points (at each visit and once weekly) •Severity scoring for dyspareunia (if sexually active) at each visit •AUC for severity scoring for dyspareunia (if sexually active) over all assessment time points (at each visit) •Impairment of daily life due to dyspareunia (if sexually active) at each visit •AUC for impairment of daily life due to dyspareunia (if sexually active) over all assessment time points (at each visit) •Overall impairment of daily life due to the condition “vaginal dryness”, including a subgroup analysis of patients with mild, moderate and severe overall impairment at each visit •AUC for overall impairment of daily life over all assessment time points (at each visit) •Vaginal Health Index, for each parameter, and as sum score over objective assessment of vaginal findings at each visit •AUC for Vaginal Health Index (for each parameter, and as sum score) over all

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Countries

Germany, Switzerland

Contacts

Public ContactClarissa Masur

Dr. August Wolff GmbH & Co. KG Arzneimittel

clarissa.masur@wolff-arzneimittel.de004905218808319

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026