Evaluation of Gynecological Acceptability of a Health Care Product (NCT04247022) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Gynecological Acceptability of a Health Care Product
Brazil74 participantsStarted 2021-04-09
Plain-language 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.
Who can participate
Age range18 Years – 59 Years
SexFEMALE
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Inclusion Criteria:
* Health volunteers
* Non-injured mucosa in the test region;
* Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19;
* Agreement to perform molecular testing to detect COVID-19 to enter the study;
* 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 59 years old (25 participants from 18 to 39 years old, 25 participants from 40 to premenopause and 25 participants in climacteria);
* Female participants;
* Vaginal dryness (slight minimum) - according to questions from the gynecologist.
Exclusion Criteria:
* Participants who belong to the risk group for COVID-19, that is, aged over 60 years, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems to belong to the risk group;
* Participants who have COVID-19, or who have symptoms indicative of the disease in the last 14 days, such as temperature above 36.8°C, fever, cough, shortness of breath, loss of smell, loss of taste and fatigue;
* 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 necrobi…