MedTrace Logo

Evaluation of Gynecological Acceptability of a Health Care Product

NCT04247022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2021-08-02

No results posted yet for this study

Summary

The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events.

The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.

Conditions

  • Atrophic Vaginitis
  • Vaginal Diseases

Interventions

OTHER

Health care product (intimate gel)

heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days

Sponsors & Collaborators

  • Herbarium Laboratorio Botanico Ltda

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2021-07-15
Completion
2021-07-15

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT04247022 on ClinicalTrials.gov