A Double Blind, Single Centric, Randomized Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Meclon (Test Product) with Placebo in theManagement of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

GIELLEPI SpA1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2019年10月6日最近更新: 2019年2月11日

试验速览

阶段: 不适用
状态: 已完成
发起方: GIELLEPI SpA
入组人数: 60
试验地点: 1
主要终点: 2.Change in subjective symptom

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This Clinical study is being planned to assess the efficacy and safety of vaginal gel in comparison with Placebo in Post Menopausal women with vulvovaginal atrophy.

In this study, 60 post menopausal women suffering with vulvovaginal atrophy will be included for a period of 12 weeks. The treatment will check for Change in objective symptoms assessed by Vaginal Health index on screening week, 2,4 and 12.

Change in subjective symptom like vaginal dryness, Vaginal Itching, Vaginal Bleeding, Burning sensation on Day 0, week 2, 4 and 12. Symptoms will be recorded by each subject daily in a diary distributed to them at visit 2.

Change in Vas score for vaginal pain and vaginal dysperunia on Day 0 to and 12.

Change in Questionnaire for FSFI on Day 0 and week 12.

The objective of the study is to assess the efficacy and safety of vaginal gel in postmenopausal women with vulvovaginal atrophy when compared to placebo.

Type of the study - Randomised placebo controlled for parallel groups.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 50.00 Year(s) 至 65.00 Year(s)（—）
性别: Female

入选标准

•1.Patient should be able to give written informed consent.
•Subjects should be postmenopausal women for atleast 2 years (age between 50 â€“ 65 years)
•Postmenopausal women with vulvovaginal atrophy
•Subject should have at least one self-assessed symptom of vulvar and vaginal atrophy (VVA): a.
•Vaginal dryness b.
•Vaginal and/or vulvar irritation/itching c.
•Vaginal pain associated with sexual activity d.
•Vaginal bleeding associated with sexual activity 5.Vaginal Health index (VHI) score during screening should be less than
•Subject with no significant illness other than vulvovaginal atrophy as judged by the Investigator
•Ability to comply with requirements of trial.

排除标准

•1.Symptomatic Vaginal infection (urogenital infections including bacterial vaginosis, aerobic vaginitis, vulvovaginal candidiasis and trichomonas) requiring treatment
•Genital bleeding of unknown cause
•History of significant risk factors for endometrial cancer and breast cancer.
•Known history of drug or alcohol abuse
•Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
•Subjects with clinically significant history of co-morbid condition (like,diabetes, immunodeficiency, HIV, HPV) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
•Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
•Subjects participating in any other studies.
•Presence of disease states that could affect safety and efficacy evaluation, such as hepatic (e.g., cirrhosis with Child-Pugh Class B or C or MELD score > 9), renal (e.g., requiring dialysis), gastrointestinal (e.g., acute or chronic diverticulitis, irritable bowel syndrome with epigastric pain as a predominant symptom or active inflammatory bowel disease), dermatological, hematologic, neurologic or brain disorders (e.g., strokes, and brain injury), psychiatric (e.g., bipolar disorder, severe active depression, severe active anxiety), or any other significant condition which, in the opinion of the Investigator, could confound or interfere with evaluation of efficacy, safety, or tolerability of the investigational drug, or prevent compliance with the study protocol.
•Known hypersensitivity to, or intolerance of, study products or their formulation excipients.