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

NCT02571127 | Unknown Phase 4 DMC

• 1 other identifier: Hidra 1
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vaginal Atrophy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Verify the tolerability and safety by identifying adverse events

  4 months

Study Arms (1)

Only treatment

EXPERIMENTAL

two weekly applications (monday and thursday or tuesday and friday) for 12 weeks

Drug: Hidra1

Interventions

Hidra1 DRUG

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.

Also known as: Parameters: Vaginal health index (VHI), Scala: pH tape, Questionnaire: Sexual Function Index female (FSFI)

Only treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Farmoquimica S.A.: lead

Study Officials

• Thales Braga, Analist

  Famorquimica SA

  STUDY CHAIR

Central Study Contacts

Fabiene Vale, Physician

CONTACT

55 31 91878133; fabienebcv@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 8, 2015

Record last verified: 2015-09