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

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Farmoquimica S.A.

Criteria

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.