NCT04342559

Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures Indicated for Women With Vaginal Drying

Evaluation Of Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures ( 06260308 ) Indicated for Women With Vaginal Drying

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Libbs Farmacêutica LTDA · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Dryness

Interventions

Type	Name	Description
OTHER	Belamy (vaginal moisturizer)	The conformity of the product use by the research participants will be verified through the filling of the product use diary by the research participants and also by the accounting of the tubes not used in T22. Interdiction and Restriction * Keep the test product tightly closed, protected from heat, moisture and out of the reach of children; * Do not apply any other product to the genital area. Only the use of soap normally used for hygiene will be allowed; * Do not change genital / vaginal hygiene habits; * Not having sexual intercourse in the 48 hours (2 days) before the research visits; * Do not perform a hygienic shower in the genital region within 24 hours (1 day) prior to the research visits; * Do not perform gynecological / intimate showers during the study period

Timeline

• Start date: 2020-04-06
• Primary completion: 2020-04-06
• Completion: 2020-04-06
• First posted: 2020-04-13
• Last updated: 2020-04-13

Locations

1 site across 1 country: Brazil