Healthy volunteers with symptoms of vaginal dryness
Conditions
Interventions
33 female participants, 40 to 70 years of age, healthy with complaints of vaginal dryness. The participants will be submitted to gynecological evaluation with gynecological examination and measurement
Device
Sponsors
Medcin Instituto da Pele Ltda
Marjan Indústria e Comércio Ltda
Eligibility
Sex/Gender
Female
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 33 female participants; aged between 40 and 70 years; with vaginal dryness, presenting normal vaginal mucosa and who want to participate in the research
Exclusion criteria
Exclusion criteria: Gestation or risk of gestation / lactation; Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to screening; active cutaneous conditions; Use of other products in the genital area; Participants who use or intend to use intravaginal or systemic anti-infectives or systemic antifungal therapy during the study; Atopic or allergic history of intravaginal products; Immunosuppression by drugs or active diseases; endocrine disorders; Relevant clinical history or current evidence of alcohol or other drug abuse; Known history or suspected intolerance to products of the same category; Intense sun exposure up to 15 days before evaluation; Dermatological and / or gynecological treatments up to 4 weeks prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To verify the safety of the investigational product, under normal conditions of use, through gynecological evaluations | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the perceived efficacy of the research product through a subjective questionnaire and pH measurements | — |
Countries
Brazil
Contacts
Public ContactFlávia Addor
Medcin Instituto da Pele Ltda
Outcome results
None listed