NCT04560283已完成4 期
Randomized Clinical Trial to Assess the Efficacy and Safety of HYDEAL-D® Application in Promoting the Restoration of Sexual Function in the Postpartum Period
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Evaluation of sexual function by FSFI
研究概览
简要总结
During postpartum and lactation, vaginal epithelium tends to have an impaired degree of hydration and lubrication. This may lead to vaginal dryness, burning sensation dyspareunia or itching, which negatively affect the sexual function of puerperal women.
This study aimed to evaluate the efficacy of HYDEAL-D® vaginal gel (HYALOGYN®, Fidia Farmaceutici, Abano Terme, Italy) application on promoting the restoration of sexual function in the postpartum period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women from 18 to 40 years old;
- •Women in the puerperium period (after vaginal delivery or cesarean section);
- •Women that are breast-feeding, that are not breast-feeding or that are breast-feeding partially;
排除标准
- •Allergy to hyaluronic acid gel;
- •Women non-Italian speaking;
- •Women with signs of vaginal infection;
- •Women with a history of cancer of any site with recent genital bleeding of unknown origin; and patients with acute hepatopathy, embolic disorders, severe primary disease of kidney;
- •Women who are attending or have attended other clinical trials within previous two weeks;
- •Women with mental disorder and no insight
研究组 & 干预措施
Experimental group receiving HYALOGYN®
Experimental
干预措施: Vaginal gel HYALOGYN® (Drug)
Control group undergoing expectant management
Placebo Comparator
干预措施: Expectant management (Behavioral)
结局指标
主要结局
Evaluation of sexual function by FSFI
时间窗: At baseline; 12 weeks
次要结局
未报告次要终点
研究者
Fabio Barra
Principal Investigator
Ospedale Policlinico San Martino
研究点 (1)
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