Clinical trial NCT02987647: Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vaginal Dryness
Lead sponsor: Farmoquimica S.A.
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 56
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women over the age of 40 years.
* Healthy Women of post-menopausal (no period for more than one year).
* Women with vaginal dryness.
* Women with active sex lives of at least 1 sexual intercourse in the month.
* Women without a history of sensitivity.
* Understanding and signing the Consent and Informed.

Exclusion Criteria:

* Women in use of any intravaginal moisturizing gel, vaginal cream and / or spermicide.
* Women with a diagnosis or history of cancer.
* Women with disease or condition that, in the opinion of the gynecologist, could affect the study results.
* Women using hormone replacement therapy in the last 3 months.
* History or visible evidence of chronic skin disease or regional infections.
* History of hypersensitivity (allergy) to promestrieno.
* Women with genital herpes, vaginal infections or urinary tract infection.
* Pregnant women and nursing mothers.
* Allergy Personal history and hypersensitivity to any feminine hygiene product.

Primary outcomes:
measure: Categories VHI scale for intensity of vaginal moisture
timeFrame: 28 days
Secondary outcomes:
measure: Score the increase in Sexual Function Index Women
timeFrame: 28 days
measure: pH vaginal
timeFrame: 28 days
measure: Acceptability of the product
timeFrame: 28 days
measure: Subjective patient evaluation
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: FQM
name: Thales Braga, analist
role: STUDY_DIRECTOR
References: