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Performance and Safety of Class IIb MD Celegyn® in VVA

NCT03823560 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-01-06

No results posted yet for this study

Summary

The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)

Conditions

  • Vulvovaginal Atrophy

Interventions

DEVICE

Celegyn®

Medical device Celegyn® presents itself as a cream.

DEVICE

Matching placebo

IP placebo presents itself as a cream.

Sponsors & Collaborators

  • Evidilya S.r.l.

    collaborator INDUSTRY

  • Nathura S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Italy

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 NCT03823560 on ClinicalTrials.gov