Vaginal DrynessPhase 4NCT02987647
Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream
A Phase 4 study testing Hidrafemme, Vagidrat and Lubrinat in people with Vaginal Dryness, run by Farmoquimica S.A..
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vaginal Dryness
- What is being tested?
- Hidrafemme, Vagidrat and Lubrinat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Vaginal Dryness
- Being tested
- Hidrafemme, Vagidrat, Lubrinat, Antrofi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HidrafemmeOther
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
VagidratOther
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
LubrinatOther
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
AntrofiOther
The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Hidrafemme | Experimental | The 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 Receives: Other: Hidrafemme |
| Vagidrat | Active comparator | The 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 Receives: Other: Vagidrat |
| Lubrinat | Active comparator | The 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 Receives: Other: Lubrinat |
| Antrofi | Active comparator | The 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 Receives: Other: Antrofi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (4)
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DrynessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thales Braga, analist, Study director, FQM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987647
- Sponsor's protocol ID
- HIDRAPILOTO
- Status last verified
- Dec 2016
- First submitted
- 3 Nov 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02987647
- Acronym / sponsor ID
- HIDRAPILOTO
- Conditions
- Vaginal Dryness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hidrafemme | Experimental | Other: HidrafemmeThe 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 comparator | Other: VagidratThe 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 comparator | Other: LubrinatThe 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 comparator | Other: AntrofiThe 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HidrafemmeThe complete treatment will have followed four weeks of duration and application of the product should take place twice a week. | Other | Hidrafemme |
| VagidratThe complete treatment will have followed four weeks of duration and application of the product should take place twice a week. | Other | Vagidrat |
| LubrinatThe complete treatment will have followed four weeks of duration and application of the product should take place twice a week. | Other | Lubrinat |
| AntrofiThe complete treatment will have followed four weeks of duration and application of the product should take place twice a week. | Other | Antrofi |
Primary outcome
Categories VHI scale for intensity of vaginal moisture
Time frame: 28 days
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
4 secondary outcomes
Score the increase in Sexual Function Index Women
Time frame: 28 days
pH vaginal
Time frame: 28 days
Acceptability of the product
Time frame: 28 days
Subjective patient evaluation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Vaginal Dryness
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Recruiting
Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
Vaginal Dryness, Menopause Symptoms
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thales Braga, analist study director
FQM
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hidrafemme, Vagidrat and Lubrinat in people with Vaginal Dryness, run by Farmoquimica S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camila Abreu, Coordenator (55 21 969553000, cabreu@fqm.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Categories VHI scale for intensity of vaginal moisture (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.