Health Condition 1: N762- Acute vulvitis
Conditions
Interventions
Intervention1: Meclon Lenex
: Gel containing the active ingredients will be administered 2 times a day, once in the
morning and once at bedtime to the vulva and vestibule for 2 consecutive weeks and t
Sponsors
GIELLEPI SpA
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 (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
Exclusion criteria
Exclusion criteria: 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 study. 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 protocol. 11. Known hypersensitivity to, or intolerance of, study products or their formulation excipients.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.Physical Examination 2.Vital Signs: Pulse rate, blood pressure and body temperature 3.Lab assessment (Hematology, Biochemistry- SGOT, SGPT,and Serum Creatinine) (needed for safety evaluation 4. Adverse Event Assessments 5. pH Quantitative test 6. Saline and 10% KOH microscopyTimepoint: Screening and 4. | — |
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction of; a. Dyspareunia b. Burning sensation c. Itching d. Erythema e.Swab test assessed by, Cotton Vulvar Pain Assessed by, Cotton swab Scoring will be according to 10cm VAS. 2.Reduction in Marinoff Dyspareunia Grade 3.Improvement of FSFI 4.Change in FSDS 5.Improvement in HRQL SF-36 6.Overall treatment satisfaction 7.Improvement of ADHS 8.Overall assessment of tolerability Timepoint: Screening, Week 1, 2 and 4. | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt Ltd
Outcome results
None listed