Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Vaginal Health Index
研究概览
简要总结
This study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).
详细描述
This is a prospective, multicenter, randomized, controlled, double-blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid-based vaginal moisturizer gel (medical device class IIb) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (Cumluade Hidratante Interno®), with a 1-month follow-up.
The participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening.
The investigators will monitor the evolution of vaginal symptoms, vaginal health using the Vaginal Health Index (VHI), sexual function using the Female Sexual Function Index (FSFI) questionnaire, and the safety and tolerability of the new class IIb medical device.
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
- Double (Participant, Investigator)
盲法说明
To maintain the double-blind, both the investigational and comparator products will be dispensed in white boxes, labeled with the study code and the patient code. Each patient code will be assigned to one treatment or the other according to a predetermined randomization list.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years of age who manifest subjective symptoms of vaginal dryness (dryness, itching, burning/stinging and dyspareunia).
- •In the case of postmenopausal women, they must have a diagnosis confirmed by the gynecologist of the presence of signs of vulvovaginal dryness/atrophy (Vaginal Health Index score <15).
- •Patients who have not used any topical treatment, moisturizer or vaginal lubricant for at least 7 days prior to the start of the study and agree not to use it during the study period.
- •Patients who agree to participate and sign the Informed Consent form.
排除标准
- •Pregnant women
- •Malignant neoplasm within 5 years prior to study entry (except for treated basal cell/squamous cell carcinoma of the skin).
- •Genital bleeding.
- •Treatment with vaginal or systemic estrogens in the 3 months prior to study inclusion or during the study period. I said above
- •Subjects with illness or other medical condition that, in the investigator's opinion, would compromise participation or could lead to hospitalization during the study.
- •Clinical evidence of acute infection that requires treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e., tuberculosis), with the exception of HPV-carrying women with no lesions.
- •Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except intermittent anxiety).
- •Known allergy to the components of the investigational product or its excipients.
- •Drug or alcohol abuse in the 12 months prior to the start of the study.
- •Participation in an interventional clinical study or administration of any investigational agent within the previous 30 days.
- •Patients with low expectation of compliance with the study protocol.
结局指标
主要结局
Vaginal Health Index
时间窗: At the end of study (Day 30)
The Vaginal Health Index ranges from a minimum of 5 to a maximum of 25. The change will be assessed by comparing scores from baseline to 30 days (final visit); with comparison intra and inter groups.
次要结局
- Global Symptom Score (GSS)(At the end of study (Day 30))
- Severity of subjective symptoms (investigator record)(at 7 days and 30 days.)
- Subjective symtomps (patient's notebook)(at 3 days, 7days, 14 days, 21 days and 30 days.)
- Vaginal pH(At the end of study (Day 30))
- Overall Safety Assessment(At the end of study (Day 30))
- Sexual function(At the end of study (Day 30))
- Adverse events as a measure of Safety and Tolerability(At the end of study (Day 30))
- Patient satisfaction(At the end of study (Day 30))
- Objective signs of vulvovaginal atrophy(at 7 days and 30 days.)