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

NCT04910906 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

  • Vaginal Atrophy

Interventions

DEVICE

Ectoin® Vaginal Gel

Ectoin® Vaginal Gel is a clear, non-hormonal moisturizing gel containing only active ingredient Ectoin® for the relief of vaginal dryness/vaginal atrophy. Other excipients in the formulation include: Hydroxyethylcellulose (Gelling agent) Lactic acid (90 %) (pH stabiliser) DL-Sodium lactate (Buffer substance) Sodium benzoate (preservative) Propylene glycol (Humectant)

Sponsors & Collaborators

  • Bitop AG

    lead INDUSTRY

Principal Investigators

  • Shatadal Sen, MSc. · Project Manager (Medical Device Development)

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2022-02-09
Completion
2022-02-09

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04910906 on ClinicalTrials.gov