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

NCT ID: NCT04342559

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2020-04-06

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.

Conditions

Vaginal Dryness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

Belamy with sinodor Vaginal Moisturizer with Odor Neutralizer - code: 062603-07

Participants will be instructed on how to use it as follows:

Guidance The product has individual pre-filled applicators for single use and disposable after use. The applicator has an anatomical shape, in order to facilitate use, avoiding discomfort during application.

A single application should be performed every 3 days (72 hours). I use it at night, before going to bed, before going to sleep.

Group Type: EXPERIMENTAL

Belamy (vaginal moisturizer)

Intervention Type: OTHER

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

Group II

Belamy without sinodor Vaginal Moisturizer without Odor Neutralizer - code: 062603-08

Participants will be instructed on how to use it as follows:

Guidance The product has individual pre-filled applicators for single use and disposable after use. The applicator has an anatomical shape, in order to facilitate use, avoiding discomfort during application.

A single application should be performed every 3 days (72 hours). I use it at night, before going to bed, before going to sleep.

Group Type: EXPERIMENTAL

Belamy (vaginal moisturizer)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Libbs Farmacêutica LTDA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Augusto Theodoro de Figueiredo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

AllSEUGEPpHFL06260307080418

Identifier Type: -

Identifier Source: org_study_id