Atrophic Vaginitis
Conditions
Interventions
Single-center clinical study, blinded to assess safety through clinical and subjective evaluations with the objective of confirming, under real conditions of use, the absence of risk of irritation and
both evaluations will be performed at the beginning and end of the study. After the initial evaluations, the couples will receive the investigational product together with a copy of the Free and Infor
Sponsors
Medcin Instituto da Pele LTDA
Helianto Farmacêutica Ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: For the female audience: female participants aged 18 to 65 years; sexually active; with vaginal dryness; heterosexual couples in a stable union or civil marriage; intact skin on the vaginal mucosa; user of products of the same category; agreement to follow the trial procedures and attend the Clinical Research Center on the days and times determined for evaluations; understanding, consenting to and signing the Free and Informed Consent Form; for the male audience: male participants aged 18 to 65 years; sexually active; heterosexual couples in a stable union or civil marriage; intact skin on the penile region; user of products of the same category; agreement to follow the trial procedures and attend the Clinical Research Center on the days and times determined for evaluations; understanding, consenting to and signing the free and informed consent form
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy and/or lactation (for women); participants with erectile dysfunction (for men); sexually transmitted infections, such as: candidiasis, trichomoniasis, gonorrhea, chlamydia or pathologies that compromise the evaluation of the safety of use of the product; use of anti-inflammatory/immunosuppressive/antihistamine drugs up to 3 weeks before selection; skin marks in the experimental area that interfere with the evaluation of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevi, sunburn); atopic or allergic history of products in the same category; active skin pathologies and/or lesions (local and/or disseminated) in the evaluation area; immunosuppression by drugs or active diseases; decompensated endocrinopathies; relevant clinical history or current evidence of alcohol or other drug abuse; known history or suspected intolerance to products in the same category; intense sun exposure up to 15 days before the evaluation; aesthetic or dermatological treatment in the evaluation area up to 4 weeks before selection; other conditions considered by the researcher as reasonable for disqualification from participation in the study. If so, it should be described in the clinical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess, under real conditions of use, the absence of risk of irritation and capture feelings of discomfort in the population studied, through dermatological and gynecological/urological assessments to evaluate the integrity of the skin and/or mucosa | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the perceived effectiveness and physical attributes of the product, through an access link to the Microsoft Forms online platform | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medcin Instituto da Pele LTDA
Outcome results
None listed