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.
试验速览
- 阶段
- 4 期
- 入组人数
- 46
- 主要终点
- Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Only treatment
two weekly applications (monday and thursday or tuesday and friday) for 12 weeks
干预措施: Hidra1 (Drug)
结局指标
主要结局
Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.
时间窗: 4 months
Evaluation of improved vaginal moisture in post menopausal women by the Vaginal health index (VHI).
时间窗: 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.
时间窗: 4 months
次要结局
- Verify the tolerability and safety by identifying adverse events(4 months)