Non-Interventional Multicentre Post-market Study of Ectoin® Vaginal Gel for Symptomatic Treatment of Vaginal Atrophy — EIC01-PMCF  

Vaginal Atrophy Clinical Trial

Official title: Prospective Post-market Clinical Follow up Study to Assess Efficacy and Safety of Ectoin® Vaginal Gel (EIC01) for Symptomatic Treatment of Vaginal Atrophy in Post-menopausal Women

Status Completed

Clinical Trial Summary

The goal of this multi-centre, prospective, open label, single arm, observational post-market clinical follow-up study (§23b of the MPG (German Medical Act) MDD 93/42/EEC and ISO14155:2020) is to investigate and evaluate the clinical efficacy of Ectoin® Vaginal gel (EIC01) to retain/restore the natural moisturization in the vaginal lumen and to alleviate vaginal atrophy symptoms.

Clinical Trial Description

A multi-centre, prospective, open label, single arm, observational post-market clinical follow-up study according to §23b of the MPG (German Medical Act) and conforming to MDD 93/42/EEC and ISO14155:2020.

Study participation will be offered to patients with symptoms of vaginal atrophy for which Ectoin® Vaginal Gel is indicated. Screening period might take up to 14 days. If the patient, at the screening visit, complies with all the inclusion criteria (except inclusion criterion No. 4 which is to be confirmed at the Baseline Visit) and she has signed the informed consent, she will be enrolled, and baseline visit will be performed on the same day.

The Ectoin® Vaginal Gel will be used for 20 days and in accordance with the IFU . Visits are scheduled on day 1, 5, and 20, at which the treatment is ended (End of treatment - EoT). Follow-up (FU) visit is planned on Day 23. Patient will record her symptoms and number of applied doses in the patient diary on daily basis, preferably around a specific time which has to be followed throughout the entire study period. Overall, participation will take at least 23 (+2) days and 37 (+2) days at maximum. The enrolment period will take 2 months. The total duration of the study is expected to be approximately 3-6 months.

The efficacy and safety of Ectoin® Vaginal Gel (EIC01) in the alleviation of vaginal atrophy symptoms will be evaluated in this study. Efficacy will be evaluated based on the improvement of Vaginal Atrophy symptoms at post-treatment measurements as compared to baseline values.

Primary endpoint is to evaluate the efficacy of the EIC01 product by analysing the difference in the sum scores of Vaginal Health Index (VHI) indicating both subjective and objective improvement in the vaginal atrophy condition after multiple application.

Secondary Endpoint:

• Improvement in individual and sum score of VAS for vaginal atrophy symptoms (feeling of dryness, itching, burning, pain during sexual intercourse) after single (immediate effect) and multiple applications

• Assessment of vaginal atrophy impact on life through Q/A

• Assessment of product acceptance and overall satisfaction through Q/A (on 20 day - V2) • Long-term treatment effect based on rate of improvement compared to baseline condition determined by subjective and objective assessments (5 days, 20 days and 23 days).

• Long-lasting effect assessed during follow-up by subjective and objective assessments on day 23.

• The treatment safety will be assessed by observation and documentation of adverse events and device deficiencies.

• Local tolerability will be assessed both by physician and patient using five-point scale (excellent, good, moderate, poor, bad). ;

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

• NCT number: NCT04910906
• Study type: Observational
• Source: Bitop AG
• Status: Completed
• Start date: May 3, 2021
• Completion date: February 9, 2022