Vaginal AtrophyPhase 4NCT02571127
Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.
A Phase 4 study testing Hidra1 in people with Vaginal Atrophy, run by Farmoquimica S.A..
Trial summary
Primary: Evaluation of improved vaginal moisture in postmenopausal women. Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of adherence to study treatment by patient diary, assessing… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Hidra1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- 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.
- in healthy postmenopausal women (not menstruating for more than one year).
- Women with vaginal dryness (VHI score in item vaginal moisture between 1-3)
- women with active sex lives of at least one sexual intercourse in the month
- Women without a history of sensitivity to similar formulations.
- understanding and signing an informed consent agreement.
Who cannot join
- Women in using other intravaginal gel moisturizer.
- Women diagnosed with cancer.
- Women with disease or condition that, in the opinion of the gynecologist, could affect the test results.
- Women using hormone replacement therapy in the last 3 months.
- Absence of history or visible evidence of chronic skin disease or regional infections.
- Women with genital herpes, vaginal infections or urinary tract infection.
- Pregnant women and nursing mothers.
- Personal history of allergy and hypersensitivity to any product of feminine hygiene.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ph IV , Longitudinal, Prospective, Open Label, Non-comparative, to Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.
Primary: Evaluation of improved vaginal moisture in postmenopausal women.
Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of adherence to study treatment by patient diary, assessing the acceptability of the product and subjective assessment of the patient as the itching and stinging / burning, beyond the safety assessment.
Read the detailed description
ENDPOINT:
- Primary: Evaluation of improved vaginal moisture in post menopausal women through vaginal health index (VHI);
- Secondaryevaluate the increase in fluid volume, vaginal elasticity and integrity of the epithelium by the VHI, evaluate the pH control, improvement of female sexual quality by applying the Sexual Function Index female (FSFI), evaluate through the patient's daily treatment adherence, evaluate the acceptability (welfare, run-off and satisfaction) of the product and the improvement of itching and stinging / burning through questionnaires and verify the tolerability and safety by identifying adverse events.
STUDY DESING: Phase IV study, longitudinal, prospective, open label, non-comparative
POPULATION: Forty-six (46) post menopausal women with vaginal dryness
DRUG: Polimers and Sodium Lactate
TREATMENT: Only treatment - two weekly applications (monday and thursday or tuesday and friday) for 12 weeks
EVALUATION: The evaluation of the effectiveness will be held on all visits by medical clinical evaluation, evaluation of symptoms resulting from the dryness (VHI), pH evaluation (pH tape) and evaluation of female sexual quality (FSFI) and subjective evaluation as well as the compliance through the patient diary. The evaluation of the acceptability of the product will be the last visit by a questionnaire. The safety assessment will be carried out on all visits by identifying adverse events
- Conditions
- Vaginal Atrophy
- Being tested
- Hidra1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hidra1Drug
Also called Parameters: Vaginal health index (VHI), Scala: pH tape, Questionnaire: Sexual Function Index female (FSFI)
Parameters: Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none / inflamed area ; 2 = no / NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal.
Will be described through the Media and Standard Deviation or median and interquartile rank , as Minimum and Maximum.
Scala: pH tape: It will be measured by its own value. Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.
| Study group | Role | What they receive |
|---|---|---|
| Only treatment | Experimental | two weekly applications (monday and thursday or tuesday and friday) for 12 weeks Receives: Drug: Hidra1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of improved vaginal moisture in post menopausal women by the Vaginal health index (VHI).
Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none / inflamed area ; 2 = no / NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal
Measured: 4 months
Scala: pH tape: It will be measured by its own value.
Measured: 4 months
Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.
Measured: 4 months
Secondary outcomes (1)
Verify the tolerability and safety by identifying adverse events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thales Braga, Analist, Study chair, Famorquimica SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571127
- Sponsor's protocol ID
- Hidra 1
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph IV , Longitudinal, Prospective, Open Label, Non-comparative, to Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.
- ClinicalTrials.gov ID
- NCT02571127
- Acronym / sponsor ID
- Hidra 1
- Conditions
- Vaginal Atrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 8 Oct 2015 (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.
Primary: Evaluation of improved vaginal moisture in postmenopausal women.
Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of adherence to study treatment by patient diary, assessing the acceptability of the product and subjective assessment of the patient as the itching and stinging / burning, beyond the safety assessment.
Detailed description
ENDPOINT:
- Primary: Evaluation of improved vaginal moisture in post menopausal women through vaginal health index (VHI);
- Secondaryevaluate the increase in fluid volume, vaginal elasticity and integrity of the epithelium by the VHI, evaluate the pH control, improvement of female sexual quality by applying the Sexual Function Index female (FSFI), evaluate through the patient's daily treatment adherence, evaluate the acceptability (welfare, run-off and satisfaction) of the product and the improvement of itching and stinging / burning through questionnaires and verify the tolerability and safety by identifying adverse events.
STUDY DESING: Phase IV study, longitudinal, prospective, open label, non-comparative
POPULATION: Forty-six (46) post menopausal women with vaginal dryness
DRUG: Polimers and Sodium Lactate
TREATMENT: Only treatment - two weekly applications (monday and thursday or tuesday and friday) for 12 weeks
EVALUATION: The evaluation of the effectiveness will be held on all visits by medical clinical evaluation, evaluation of symptoms resulting from the dryness (VHI), pH evaluation (pH tape) and evaluation of female sexual quality (FSFI) and subjective evaluation as well as the compliance through the patient diary. The evaluation of the acceptability of the product will be the last visit by a questionnaire. The safety assessment will be carried out on all visits by identifying adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only treatment | Experimental | Drug: Hidra1two weekly applications (monday and thursday or tuesday and friday) for 12 weeks |
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.
- in healthy postmenopausal women (not menstruating for more than one year).
- Women with vaginal dryness (VHI score in item vaginal moisture between 1-3)
- women with active sex lives of at least one sexual intercourse in the month
- Women without a history of sensitivity to similar formulations.
Key exclusion criteria (8 listed)
- Women in using other intravaginal gel moisturizer.
- Women diagnosed with cancer.
- Women with disease or condition that, in the opinion of the gynecologist, could affect the test results.
- Women using hormone replacement therapy in the last 3 months.
- Absence of 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 |
|---|---|---|
| Hidra1Also: Parameters: Vaginal health index (VHI), Scala: pH tape, Questionnaire: Sexual Function Index female (FSFI)Parameters: Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none / inflamed area ; 2 = no / NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal. Will be described through the Media and Standard Deviation or median and interquartile rank , as Minimum and Maximum. Scala: pH tape: It will be measured by its own value. Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient. | Drug | Only treatment |
Primary outcome
Evaluation of improved vaginal moisture in post menopausal women by the Vaginal health index (VHI).
Time frame: 4 months
Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none / inflamed area ; 2 = no / NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal
Scala: pH tape: It will be measured by its own value.
Time frame: 4 months
Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.
Time frame: 4 months
1 secondary outcome
Verify the tolerability and safety by identifying adverse events
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
Related trials for Vaginal Atrophy
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
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
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 chair
Famorquimica SA
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hidra1 in people with Vaginal Atrophy, 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 8 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 8 Oct 2015. 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 Fabiene Vale, Physician (55 31 91878133, fabienebcv@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of improved vaginal moisture in post menopausal women by the Vaginal health index (VHI). (time frame: 4 months). The study lists 3 primary outcomes in all. 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 8 Oct 2015.