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Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

NCT04245358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-10

No results posted yet for this study

Summary

This study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.

Conditions

  • Vaginal Disease

Interventions

DEVICE

Ainara

1g of gel per administration

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Liviu Cristian PĂTRAȘCU, MD · Fizio Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2019-12-09
Completion
2019-12-09

Countries

  • Romania

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 NCT04245358 on ClinicalTrials.gov