Phase IV Pilot, Longitudinal, Prospective, Double-blind, Comparative to Assess the Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream in Postmenopausal Women

Before any procedure of the study, the researcher should have undertaken a detailed discussion on the Consent and Informed remedying any questions the patient may present. Then the principal investigator and the patient must sign all pages of the Consent and Informed (two-way), each one with a copy. Female patients aged above 40 years postmenopausal and who are diagnosed with vaginal dryness, will be invited to participate in this study. After the selection, through the inclusion and exclusion criteria, and signing the consent form Clarified, research participants will be evaluated by clinical examination (VHI), pH evaluation (using pH tape), questionnaire application IFSF and subjective evaluation of the patient. All the above procedures will be performed in own research center for the study team. The study in question has four (4) treatment groups with fourteen (14) patients each, totaling fifty-six (56) patients. The allocation of these patients will occur blind, parallel to the first group use the Hidrafemme, the second uses the Vagidrat, uses the third and fourth Lubrinat use the Antrofi. All groups conduct the use of those products, twice a week for four (4) consecutive weeks. After the addition, the research participant will receive the product under study and will be oriented as their dosage, correct application form and the records in the patient diary.

After the Visit 1 (initial) the research participant must return for another visit in person, Visit 2 (final), the research center, which will take place 28 calendar days after the date of Visit 1 (initial). During all the above visits, the participants research will be assessed by the principal investigator and will be conducted the subjective evaluation of the patient, VHI evaluation (attached), pH control and will fill the IFSF form (attached). At the final visit will be also evaluated the acceptability of the product and adherence to treatment through the patient diary. The adverse event occurrences will be evaluated during the final visit. If any research participant submit an adverse event, it will be accompanied by research center staff to its resolution. The variables related to the effectiveness of the product will be studied by VHI scale, which indicates the score of each item under study. The score should be evaluated for each variable. Daily application for registration throughout the period of four (4) weeks, and the product will be dispensed after the inclusion / randomization of the patient during the initial visit, sufficient to twenty-eight (28) days of treatment.