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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02571127
Other study ID # Hidra 1
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 1, 2015
Last updated October 6, 2015
Start date October 2015
Est. completion date March 2016

Study information

Verified date September 2015
Source Farmoquimica S.A.
Contact Fabiene Vale, Physician
Phone 55 31 91878133
Email fabienebcv@yahoo.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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 the acceptability of the product and subjective assessment of the patient as the itching and stinging / burning, beyond the safety assessment.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date March 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Hidra1
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Farmoquimica S.A.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 months No
Primary Scala: pH tape: It will be measured by its own value. 4 months No
Primary Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient. 4 months No
Secondary Verify the tolerability and safety by identifying adverse events 4 months No
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