Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream
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
1 other identifier
interventional
56
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2017
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedDecember 9, 2016
December 1, 2016
2 months
November 3, 2016
December 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Score the increase in Sexual Function Index Women
28 days
pH vaginal
28 days
Acceptability of the product
28 days
Subjective patient evaluation
28 days
Study Arms (4)
Hidrafemme
EXPERIMENTALThe arm in question will have 14 patients who use the Hidrafemme product, encoded as group A. Name: hidrafemme Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
Vagidrat
ACTIVE COMPARATORThe arm in question will have 14 patients who use the Vagidrat product, encoded as group B. Name: vagidrat Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
Lubrinat
ACTIVE COMPARATORThe arm in question will have 14 patients who use the Lubrinat product, encoded as group C. Name: lubrinat Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
Antrofi
ACTIVE COMPARATORThe arm in question will have 14 patients who use the Antrofi product, encoded as group D. Name: antrofi Dosage form: applicator Dosage: the applicator must be complete (full) Frequency: twice a week Duration: 28 days
Interventions
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Thales Braga, analist
FQM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2016
First Posted
December 9, 2016
Study Start
January 1, 2017
Primary Completion
March 1, 2017
Study Completion
April 1, 2017
Last Updated
December 9, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share