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.
Status | Not yet recruiting |
Enrollment | 56 |
Est. completion date | April 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Farmoquimica S.A. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Categories VHI scale for intensity of vaginal moisture | The efficacy parameter: intensity of vaginal moisture; It will be measured by the VHI: 1 = no / inflamed surface; 2 = no / not inflamed surface; 3 = minimal, 4 = moderate, 5 = Normal. They will be described by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA measures and where there are significant differences will be a post hoc Tukey and Dunnet. 95% confidence intervals for the mean difference will be calculated | 28 days | No |
Secondary | Score the increase in Sexual Function Index Women | The score index of female sexual function (SIFIs) will be described on a monthly basis by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA test and if there are no significant differences will be performed post hoc Tukey and Dunnet as appropriate. 95% confidence intervals for the mean differences in each visit will be calculated. | 28 days | No |
Secondary | pH vaginal | It will be measured by its own value, described on a monthly basis by mean and standard deviation or median and interquartile range, as well as minimum and maximum. If there is a normal distribution and equal variance will be held the Split-Plot ANOVA test and if there are no significant differences will be performed post hoc Tukey and Dunnet as appropriate. 95% confidence intervals for the mean differences in each visit will be calculated. | 28 days | No |
Secondary | Acceptability of the product | The acceptability of the product will be assessed by the patient using a satisfaction scale: 1 = very satisfied, 2 = satisfied, 3 = makes no difference, 4 = dissatisfied and 5 = very dissatisfied And others. | 28 days | No |
Secondary | Subjective patient evaluation | Patients will assess all visits the intensity of itching and stinging / burning of the vagina on a scale such as: 1 = Severe 2 = Moderate; 3 = mild; 4 = no For the variables: Fire / vaginal burning will be summed up at all visits, in terms of mean and sta or Kruskal-Wallis depending on if there is a normal distribution and equal variance. | 28 days | No |
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