Clinical trial NCT04342559: Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures Indicated for Women With Vaginal Drying
Official title: Evaluation Of Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures ( 06260308 ) Indicated for Women With Vaginal Drying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Dryness
Keywords: vaginal hydration
Lead sponsor: Libbs Farmacêutica LTDA
Sponsor class: INDUSTRY
First posted: 2020-04-13
Enrollment: 74
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, non-comparative clinical study.
Primary purpose: TREATMENT

Brief summary: The studies carried out to evaluate the safety and efficacy of products aimed at the intimate area of women aim to confirm the absence of risk associated with its use, identify possible feelings of discomfort and / or clinical signs resulting from the use of the product and evaluate the benefits provided by the use of the product such as, gynecologically tested, clinically tested, hydration for 72 hours, hydration, does not drip or drip little, feeling of natural hydration, control of natural vaginal odor, preserves vaginal pH, does not promote irritation, use vaginal topic, feeling of comfort, relief from dryness, easy use of the applicator, the applicator does not cause discomfort during application, preferably use at night, does not change the vaginal flora, reduces pain and discomfort during or shortly after sexual intercourse, does not promote discomfort during or shortly after intercourse, reduction of vaginal bleeding during or right after sexual intercourse, if there is a small amount left in the applicator, the treatment is not compromised.

The research will be carried out with two new products for use in the internal intimate region in up to 74 research participants (up to 37 participants per product - each group of 37 will use one of the products), which meet the required inclusion and exclusion criteria. At the end of the treatment, the analysis must contain a minimum number of 30 participants per product. Participants will use the test products for 22 (+ 2) days and will be evaluated and monitored throughout the study by a gynecologist to verify the effectiveness of the products and possible adverse events. In addition, a profile questionnaire will be applied at the beginning of the study (T0 - day 1) and at the end of the study, the perceived efficacy questionnaire (T22), to assess signs and symptoms of the efficacy and safety of the product used.

Detailed description: Moisturizers are used in chronic maintenance, replacing normal vaginal sections.

Vaginal moisturizers rehydrate the mucosal tissue and are absorbed by the skin, adhering to the vaginal lining, thus mimicking natural vaginal secretions. The use of vaginal moisturizers is intended to allow dryness / atrophy, vaginitis / non-hormonal vaginal atrophy and is regularly harmful or once every 2-3 days. The frequency of use is directly proportional to the severity of the atrophy (for example, the more severe the atrophy, the more frequent the application is), the effects of the moisturizer are more prolonged and the effects of the lubricant, lasting 2 to 3 days.

MOD_PRO_CEP Rev. 03 All-SE-UG-EP-pH-FL-062603-07 / 08-04-18-PRV01 Vaginal moisturizers use this longer to change the content of the endothelium fluid, capture the vaginal pH and thus maintain vaginal hydration and acidity. Therefore, they are particularly beneficial, not only for women with VVA / GSM symptoms that cause pain during intercourse, but also for women who are not currently sexually active, but experience discomfort on a daily basis. Since vaginal moisturizers are used to moisturize the mucosa, most contain water. For the water to stick to the mucosa, it also contains vegetable or synthetic polymers. In addition, they can use a wide variety of other excipients to provide adequate viscosity, to buffer or pH and for conservation; these additional ingredients (some synthetic polymers) affect the pH and osmolality of the moisturizer.

The products to be tested in this study are two vaginal moisturizers. These are two new products from the sponsor.

Eligibility criteria: Inclusion Criteria:

* Healthy research participants with an active sex life;
* Skin and intact mucosa in the test region;
* Agreement to adhere to the study's procedures and requirements and to attend the institute on the day (s) and time (s) determined for the assessments;
* Ability to consent to their participation in the study;
* Female research participants;
* Menopausal participants of any age;
* Participants who complain of vaginal dryness, classified at least as mild, and who present at least one of the following symptoms, in addition to vaginal dryness, also classified at least as mild (pain during or shortly after intercourse or discomfort during or soon after sexual intercourse).

Exclusion Criteria:

* Have used moisturizing creams and / or vaginal lubricants 05 days before the initial study visit;
* Vaginal pathology in the product application area;
* Have had sex less than 48 hours before the visit;
* Have been diagnosed with urogenital or vaginal infection in the last 30 days;
* Have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last six weeks;
* Immune failure;
* Current use of the following medications for topical or systemic use: corticosteroids, immunosuppressants and antihistamines and in the last 7 days;
* History of reaction to the category of the product tested;
* Present vaginal bleeding on the day of visits;
* Other diseases or medications that may directly interfere with the study result or endanger the health of the research participant, at the discretion of the investigator.

Primary outcomes:
measure: Intensity of clinical signs (Visual gynecological examination)
timeFrame: day 1
measure: Intensity of clinical signs (Visual gynecological examination)
timeFrame: day 22
measure: Vaginal pH measurements
timeFrame: day 1
measure: Vaginal pH measurements
timeFrame: day 22
measure: Bacterioscopic collection
timeFrame: days 1 and 22
measure: Visual assessment of product accumulation in the mucosa
timeFrame: after 72 hours
measure: Vaginal Health Index
timeFrame: after 72 hours
measure: Teste de Contato (patch test)
timeFrame: up to 22 day
Secondary outcomes:
measure: Evaluation of Effectiveness Perceived by Research Participants
timeFrame: day 1
measure: Evaluation of Effectiveness Perceived by Research Participants
timeFrame: day 22
measure: Rate of Gynecological Adverse Reactions
timeFrame: up to 22 day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Augusto Theodoro de Figueiredo
Study officials:
References: