Vaginal Dryness Clinical Trial
Official title:
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
To evaluate the perception of the effectiveness of Hidrafemme® gels, Vagidrat®, Lubrinat and Antrofi cream in improving vaginal moisture in postmenopausal women who are currently registered options most current and available in the market in order to assess the differences between them, subsequently conduct a clinical study larger.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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