CTRI/2019/05/019113已完成未知
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.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- GIELLEPI SpA
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patient should be able to give written informed consent.
- •2. Subjects should be postmenopausal women for atleast 2 years (age between 50 â?? 65 years)
- •3. Postmenopausal women with vulvovaginal atrophy
- •4. 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 15.
- •6. Subject with no significant illness other than vulvovaginal atrophy as judged by the Investigator
- •7. 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
- •2. Genital bleeding of unknown cause
- •3. History of significant risk factors for endometrial cancer and breast cancer.
- •4. Known history of drug or alcohol abuse
- •5. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •6. 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.
- •7. Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
- •8. Subjects participating in any other studies.
- •9. 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.
- •10. Known hypersensitivity to, or intolerance of, study products or their formulation excipients.
研究者
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