Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Atrophy
• Intervention / Treatment: Drug: Hidra1

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Only treatment; two weekly applications (monday and thursday or tuesday and friday) for 12 weeks

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.; Other Names: Parameters: Vaginal health index (VHI); Scala: pH tape; Questionnaire: Sexual Function Index female (FSFI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Scala: pH tape: It will be measured by its own value.		4 months
Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.		4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Verify the tolerability and safety by identifying adverse events	4 months

Collaborators and Investigators

• Sponsor: Farmoquimica S.A.
• Investigators: Study Chair: Thales Braga, Analist, Famorquimica SA

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: Hidra 1