vulvovaginal atrophy MedDRA version: 21.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Vagisan
Product Name: Vagisan
Pharmaceutical Form: Pessary
INN or Proposed INN: (S)-Milchsäure and Natrium-(S)-lactat-Lösung (entspr. 40 mg Milchsäure).
Other descriptive name: LACTIC ACID
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Post-menopausal women with the subjective symptomatology of “vulvovaginal and atrophy" with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VMI of =65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: •Known hypersensitivity against any of the ingredients of the test products. •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. •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 atrophy". •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 product, applied intravaginally or on the vulva during the conduct of this trial. •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. •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 wards, prisons or state institutions. •Participation in a clinical trial with investigational medicinal products within the last 30 days prior to the start of this study and / or during this trial. •Patients underlying any other restrictions due to the participation in other tests / test institutes. •Employees of the study sites who are directly involved in this trial or employees of the Sponsor’s company. •If in the opinion of the investigator the patient should not participate in the study for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to investigate the changes in the Vaginal Maturation Index (VMI) during the course of the trial ;Secondary Objective: •Evaluation of the Day-to-Day impact of Vaginal Aging Questionnaire (DIVA) •Vaginal Health Index (investigator's assessment of vaginal findings: fluid secretion, moisture, overall elasticity, pH, epithelia mucosa). •Vaginal status of Lactobacillus flora (normal range, increased, decreased). •Subjective symptoms of atrophy (dryness, itching, burning and pain unrelated to sexual intercourse), and dyspareunia Safety Assessments: •Global judgement of tolerability by the Investigator •Global judgement of tolerability by the patient •Premature trial termination due to adverse reactions •Safety parameters (adverse events, concomitant medication, blood pressure and pulse rate) ;Primary end point(s): The comparison of the mean VMI between Day 1 and Day 43 ;Timepoint(s) of evaluation of this end point: D1 and Day 43 (after 6 weeks treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Comparisons of each assessment time (Day 1 to 8, Day 8 to 43, and Day 1 to 43) for: oSum scores of each of the four categories of the DIVA questionnaire (daily activities, emotional well-being, sexual functioning, self-concept and body image) oDIVA total score including all four categories oVMI (except Day 1 to 43) oVHI for each parameter, and as sum score over objective assessment of vaginal findings oSeverity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) at each assessment time and as sum score over subjective assessment of vaginal findings at each assessment time oSeverity scoring for dyspareunia (if sexually active) •Vaginal status of Lactobacillus Flora Safety assessments: •Global judgment of the tolerability by the Investigator on Day 43 •Global judgment of the tolerability by the patient on Day 43 •Premature trial termination due to adverse reactions •Safety parameters (adverse events, concomitant medication, blood pressure and pulse rate) ;Timepoint(s) of evaluation of this end point: timepoints of evaluation for DIVA questionnaire, VHI, VMI subjective symptoms, severity of dyspareunia and vaginal status of Lactobacillus are Day 1, Day 8 and Day 43 Timepoint for evaluation of tolerability by patient and investigator is Day 43. timepoints for evaluation of safety parameter AE and concomittant medication are Day 1, Day 8 and Day 43 Timepoint of Evaluation of blood pressure and pulse rate are Day 1 and Day 43. | — |
Countries
Germany
Contacts
Public ContactClarissa Masur
Dr. August Wolff GmbH & Co. KG Arzneimittel
Outcome results
None listed