Noninflammatory disorder of vagina, unspecified
Conditions
Interventions
After signing the Free and Informed Consent Term, the 62 research participants will be submitted to individual clinical evaluation to check the inclusion and non-inclusion criteria by the gynecologist
Sponsors
INFAN - Indústria Química e Farmacêutica Nacional
INFAN - Indústria Química e Farmacêutica Nacional
Kosmoscience Ciência e Tecnologia Cos Imp Exp Ltda
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Female participants; Participants complaining of vaginal dryness and active sex life; Age between 18 to 65 years; Examination of gynecological inspection must be normal; Agreement to obey the trial procedures and attend the clinic on the days and times determined for medical evaluations; Understand, consent and sign the Free and Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: Pregnancy or pregnancy risk; Lactation; Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study); Active skin pathologies (local and / or disseminated) in the evaluation area; Pathologies that cause suppression of immunity, such as diabetes, HIV, etc .; Endocrine pathologies such as thyroid diseases, ovarian or adrenal gland disorders; Any infection in the product analysis region diagnosed at the time of inclusion; Other conditions considered by the investigating physician as reasonable for the individual's disqualification from participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvements in vaginal hydration are expected to be seen in 85% of patients by gynecological evaluation after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactMarcelo Oliveira
INFAN - Indústria Química e Farmacêutica Nacional
Outcome results
None listed