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CTRI Number  CTRI/2021/07/034644 [Registered on: 07/07/2021] Trial Registered Prospectively
Last Modified On: 24/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on a vulvo-vaginal gel 
Scientific Title of Study   A Randomized, Double Blind, Single Centric, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Meclon Lenex In Fertile Women Diagnosed With Vulvar Vestibulitis And Non-Infective Vulvitis. 
Trial Acronym  GLI_SCRS_MVLG_2020 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Urvashi P Bhatara 
Designation  Principal Investigator 
Affiliation  Rajalakshmi Hospital and Research Centre 
Address  Rajalakshmi Hospital and Research Center, Department of Gynaecology, First Floor, Room No.1 Lakshmipura Main Road, Vidyaranyapura Post.

Bangalore
KARNATAKA
560097
India 
Phone  9448696741  
Fax    
Email  urvashibhatara@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Subramanian 
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt Ltd 
Address  Syncretic Clinical Research Services Pvt. Ltd. No.32, Door No. 4, 5th Cross, 11th Main, Vasanthnagar.

Bangalore
KARNATAKA
560052
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian 
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt Ltd 
Address  Syncretic Clinical Research Services Pvt. Ltd. No.32, Door No. 4, 5th Cross, 11th Main, Vasanthnagar.

Bangalore
KARNATAKA
560052
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
GIELLEPI S.p.A Sede Legale: Via Saffi, 21-20123 Milano Sede Operativa:Via B. Celini, 37-20851 Lissone (MB) ITALY  
 
Primary Sponsor  
Name  GIELLEPI SpA 
Address  GIELLEPI S.p.A Sede Legale: Via Saffi, 21-20123 Milano Sede Operativa:Via B. Celini, 37-20851, Lissone (MB), Italy 
Type of Sponsor  Other [Manufacturer, Limited Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Urvashi Bhatara  Rajalakshmi Hospital and Research Centre  Rajalakshmi Hospital and Research Center, Department of Gynaecology, First Floor,Room No.1 Lakshmipura Main Road, Vidyaranyapura Post.560097
Bangalore
KARNATAKA 		 09448696741

urvashibhatara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N762||Acute vulvitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 then for the next 2 weeks the product will be administered only at bedtime for 3 times a week. 
Comparator Agent  Placebo  Gel containing no 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 then for the next 2 weeks the product will be administered only at bedtime for 3 times a week. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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 (“Friedrich’s Criteria”),
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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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
 		 Screening, Week 1, 2 and 4. 
 
Secondary Outcome  
Outcome  TimePoints 
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 microscopy 		 Screening and 4. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/07/2021 
Date of Study Completion (India) 29/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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. 




 
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