CTRI/2021/07/034644已完成未知
A Randomized, Double Blind, Single Centric, Placebo Controlled Study To EvaluateThe Efficacy And Safety Of Meclon Lenex In Fertile Women Diagnosed With VulvarVestibulitis And Non-Infective Vulvitis. - GLI_SCRS_MVLG_2020
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- GIELLEPI SpA
- 入组人数
- 40
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. Adult women (18-45years old).
- •3. Patients diagnosed with vulvar vestibulitis if they meet the following
- •a. history of vulvar pain with tampon insertion or attempted
- •intromission,
- •b. focal areas of erythema confined to the vulvar vestibule,
- •c. tenderness upon palpation of these areas with a cotton tipped
- •applicator (ââ?¬Å?Friedrichââ?¬•s Criteriaââ?¬?),
- •d. exclusion of other causes for these findings,
- •e. symptoms present for 3 months or more.
- •4. Patients with coexisting vulvovaginal candidiasis, on maintenance
- •with azole and negative follow up fungal cultures, yet still fulfilled
- •the criteria for vulvar vestibulitis.
- •5. Patients not taking any other therapy for vulvar vestibulitis for at least
- •a month before enrolment.
- •6. Ability to comply with requirements of trial
排除标准
- •1. Pregnant and lactating women.
- •2. Subjects with clinically significant history of co-morbid condition
- •and other specific neuropathology, atrophic vaginitis, dermatitis such
- •as vulvar dystrophy, or pathogens such as culture/smear-proven
- •Candida spp. or Herpes simplex.
- •3. Subjects on hormone replacement therapy or chemotherapy or
- •radiotherapy.
- •4. Subjects participating in any other clinical studies or participated in
- •any clinical trial 3 months prior to start of this trial.
- •5. Genital bleeding of unknown cause.
- •6. Known history of malignancy.
- •7. Known history of drug or alcohol abuse.
- •8. Subjects who, in the opinion of the investigator, are mentally
- •incapacitated such that informed consent cannot be obtained.
- •9. 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
- •10. 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
- •11. Known hypersensitivity to, or intolerance of, study products or their
- •formulation excipients.
研究者
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