Trial | NCT04327947  Report issue

Title

Evaluation of Gynecological Acceptability of 3 Health Care Products
Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    65
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.
At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.
Study Started
Nov 06
2019
Primary Completion
Dec 10
2019
Study Completion
Feb 21
2020
Last Update
Apr 03
2020

Other Hyaluronic acid - Research product 1

Health care product (intimate gel)

Other Hyaluronic acid - Research product 2

Health care product (intimate gel)

Other Hyaluronic acid - Comparator product

Health care product (intimate gel)

women, 18-39 y Experimental

Health volunteers, 18-39 y, with vaginal dryness

premenopause women Experimental

Health volunteers, 40 years to premenopause, with vaginal dryness

climacteric women Active Comparator

Health volunteers, climacteric, with vaginal dryness

Criteria 

Inclusion Criteria:

Health volunteers
Non-injured mucosa in the test region;
Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations;
Ability to consent to their participation in the study;
Age from 18 to 70 years old;
Female participants;
Vaginal dryness (slight minimum) - according to questions from the gynecologist.

Exclusion Criteria:

Pregnancy or breastfeeding;
Skin pathology in the area of application of the product;
Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma;
Current use of the following medications for topical or systemic use:

corticosteroids, immunosuppressants and antihistamines;

Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
History of reaction to the category of the tested product;
Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.
No Results Posted