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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GIELLEPI SpA
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Reduction of;
研究概览
简要总结
This clinical study is planned on 40 female subjects with vulvar vestibulitis and non-infective vulvitis for a period of 4 weeks. This study is to assess the efficacy and safety of the test product (vaginal gel) with that of the comparator which is placebo. As this is a single centric study, study is planned to be conducted at a clinical site having an Institutional Ethics committee, which is registered with CDSCO. Study will be conducted according to ICH and GCP Guidelines.
Subjects diagnosed with vulvar vestibulitis and non-infective vulvitis satisfying all the inclusion/exclusion criteria will be identified and screened for the study. Subjects will be screened on the basis of demographics, physical examination including vital signs, medical history, medication history, Lab investigations will be performed, vaginal and vulvar symptoms (Freidrich’s Criteria), vulvar cotton swab and Marinoff Dyspareunia Grade will be performed and recorded in the respective forms. Concomitant medication will be recorded.
The treatment wil check for reduction in dyspareunia, burning sensation, itching and erythema. Reduction of Marinoff dyspareunia, improvement in sexual activity and change in female sexual distress scale. Improvement in HRQL-SF36, improvement in ADHS. All these will be assessed on screening, week1,2 and 4.
Type of the study- Randomized 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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient should be able to give written informed consent.
- •Adult women (18-45years old).
- •Patients diagnosed with vulvar vestibulitis if they meet the following criteria: 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 (“Friedrich’s Criteriaâ€), d.
- •exclusion of other causes for these findings, e.
- •symptoms present for 3 months or more.
- •Patients with coexisting vulvovaginal candidiasis, on maintenance with azole and negative follow up fungal cultures, yet still fulfilled the criteria for vulvar vestibulitis.
- •Patients not taking any other therapy for vulvar vestibulitis for at least a month before enrolment.
- •Ability to comply with requirements of trial.
排除标准
- •Pregnant and lactating women.
- •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.
- •Subjects on hormone replacement therapy or chemotherapy or radiotherapy.
- •Subjects participating in any other clinical studies or participated in any clinical trial 3 months prior to start of this trial.
- •Genital bleeding of unknown cause.
- •Known history of malignancy.
- •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.
- •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.
结局指标
主要结局
1.Reduction of;
时间窗: Screening, Week 1, 2 and 4.
b. Burning sensation
时间窗: Screening, Week 1, 2 and 4.
c. Itching
时间窗: Screening, Week 1, 2 and 4.
d. Erythema
时间窗: Screening, Week 1, 2 and 4.
Scoring will be according to 10cm VAS.
时间窗: Screening, Week 1, 2 and 4.
5.Improvement in HRQL SF-36
时间窗: Screening, Week 1, 2 and 4.
6.Overall treatment satisfaction
时间窗: Screening, Week 1, 2 and 4.
7.Improvement of ADHS
时间窗: Screening, Week 1, 2 and 4.
Vulvar Pain Assessed by,
时间窗: Screening, Week 1, 2 and 4.
a. Dyspareunia
时间窗: Screening, Week 1, 2 and 4.
e.Swab test assessed by,
时间窗: Screening, Week 1, 2 and 4.
Cotton
时间窗: Screening, Week 1, 2 and 4.
Cotton swab
时间窗: Screening, Week 1, 2 and 4.
2.Reduction in Marinoff Dyspareunia Grade
时间窗: Screening, Week 1, 2 and 4.
3.Improvement of FSFI
时间窗: Screening, Week 1, 2 and 4.
4.Change in FSDS
时间窗: Screening, Week 1, 2 and 4.
8.Overall assessment of tolerability
时间窗: Screening, Week 1, 2 and 4.
次要结局
- 1.Physical Examination(2.Vital Signs: Pulse rate, blood pressure and body temperature)