| CTRI Number |
CTRI/2019/05/019113 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of a gel to be applied locally for adult female whose periods have stopped and who are having thinning, drying, swelling, pain and redness in the vagina. |
|
Scientific Title of Study
|
A Double Blind, Single Centric, Randomized Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Meclon (Test Product) with Placebo in the
Management of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women. |
| Trial Acronym |
|
|
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 |
| Address |
Rajalakshmi Hospital
Department of OBG
Ground Floor
Lakshmipura Main Road
Vidyaranyapura Post
Bangalore
KARNATAKA
560097
India |
| Phone |
|
| Fax |
|
| Email |
urvashibhatara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
Chief Executive Officer |
| Affiliation |
Syncretic Clinical Research Services Pvt Ltd |
| Address |
Syncretic Clinical Research Services Pvt Ltd
No 32 Door No 4 (Old No.38)
5th cross 11th Main
Vasanthnagar.
Bangalore
KARNATAKA
560052
India |
| Phone |
|
| Fax |
|
| Email |
deepa@syncretic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
Chief Executive Officer |
| Affiliation |
Syncretic Clinical Research Services Pvt Ltd |
| Address |
Syncretic Clinical Research Services Pvt Ltd
No 32 Door No 4 (Old No.38)
5th cross 11th Main
Vasanthnagar.
Bangalore
KARNATAKA
560052
India |
| Phone |
|
| 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 |
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
|
|
|
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 P Bhatara |
Rajalakshmi Hospital |
Department of OBG
First Floor Lakshmipura Main Road Vidyaranyapura Post
Bangalore
KARNATAKA |
9448696741
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
The 5ml placebo gel contained in the applicator will be inserted into vagina once daily during bedtime for 2 weeks then a maintenance dose for the rest of the course of trial which will be 2 times per week for 10 weeks. |
| Intervention |
Sea berry oil (Hippophae rhamnoides)
Aloe vera (Aloe barbadensis) leaf juice |
The 5ml test gel contained in the applicator will be inserted into vagina once daily during bedtime for 2 weeks then a maintenance dose for the rest of the course of trial which will be 2 times per week for 10 weeks. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient should be able to give written informed consent.
2. Subjects should be postmenopausal women for atleast 2 years (age between 50 – 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in objective symptoms assessed by Vaginal Health index
2.Change in subjective symptom
â–ª Vaginal dryness
â–ª Vaginal Itching
â–ª Vaginal Bleeding
â–ª Burning Sensation
3.Change in VAS scoring for Vaginal pain and Vaginal Dyspareunia
4.Overall treatment satisfaction questionnaire and tolerability
5.Improvement of sexual activity using
FSFI questionnaire score. |
Screening, Week 2, 4 and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Physical Examination
2.Any reports of adverse or serious adverse events during the treatment period.
3.Significant change in laboratory parameters
4.Any abnormal vital signs. |
Screening, Week 2, 4 and 12 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/06/2019 |
| Date of Study Completion (India) |
30/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
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 being planned to assess the efficacy and safety of vaginal gel in comparison with Placebo in Post Menopausal women with vulvovaginal atrophy. In this study, 60 post menopausal women suffering with vulvovaginal atrophy will be included for a period of 12 weeks. The treatment will check for Change in objective symptoms assessed by Vaginal Health index on screening week, 2,4 and 12. Change in subjective symptom like vaginal dryness, Vaginal Itching, Vaginal Bleeding, Burning sensation on Day 0, week 2, 4 and 12. Symptoms will be recorded by each subject daily in a diary distributed to them at visit 2. Change in Vas score for vaginal pain and vaginal dysperunia on Day 0 to and 12. Change in Questionnaire for FSFI on Day 0 and week 12.
The objective of the study is to assess the efficacy and safety of vaginal gel in postmenopausal women with vulvovaginal atrophy when compared to placebo.
Type of the study - Randomised placebo controlled for parallel groups. |