| CTRI Number |
CTRI/2025/08/093368 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Combination therapy with Probiotics and Estrogen vaginal cream versus Estrogen vaginal cream for treatment of urinary and genital problems in Postmenopausal women |
|
Scientific Title of Study
|
Combination therapy with Probiotics and Estrogen vaginal cream versus Estrogen vaginal cream for treatment of genitourinary syndrome in Postmenopausal women – A Randomized open label clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bommareddy Pooja |
| Designation |
post graduate |
| Affiliation |
SRM Medical College Hospital and research center |
| Address |
SRM medical college hospital and research center, Potheri
Kattankulathur- 603203
Tamil nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9010915705 |
| Fax |
|
| Email |
pooja.nsm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthiga Prabhu |
| Designation |
Professor, MS.OBGY |
| Affiliation |
SRM Medical College Hospital and research centre |
| Address |
SRM medical college hospital and research center, Potheri
Kattankulathur- 603203
Tamil nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894269895 |
| Fax |
|
| Email |
j.karthigaprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bommareddy Pooja |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital and research centre |
| Address |
SRM medical college hospital and research center, Potheri
Kattankulathur- 603203
Tamil nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09010915705 |
| Fax |
|
| Email |
pooja.nsm@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,
POTHERI, KATTANKULATHUR
TAMIL NADU- 603203
INDIA |
|
|
Primary Sponsor
|
| Name |
Dr.Bommareddy Pooja |
| Address |
SRM medical college hospital and research center,potheri, kattankulathur
KANCHEEPURAM DISTRICT
TAMIL NADU- 603203
INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 Bommareddy Pooja |
SRM medical college hospital and research centre |
I-G Block,04, Department of Obstetrics and Gynaecology,SRM medical college hospital and research centre
Potheri,Kattankulathur- 603203
Kancheepuram
TAMIL NADU |
9010915705
pooja.nsm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N958||Other specified menopausal and perimenopausal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral probiotics and vaginal estrogen cream
|
Multiflora-V per oral 1 tablet daily at night after food for 3months and
estrogen cream(0.1% estriol cream) per vaginum to be applied in the upper vagina at bedtime for first two weeks followed by twice weekly till 8weeks as maintainence dose |
| Comparator Agent |
Vaginal estrogen cream |
vaginal estrogen cream(0.1% estriol cream) per vaginum to be applied in the upper vagina everyday at bedtime for 2weeks followed by twice weekly till 8weeks as maintainence dose. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women with genitourinary syndrome
Diagnosis of GSM in our study will be based on the presence of at least 1 symptoms with pH more than or equal to 4.5 and the symptoms not attributed to any other pathology
Symptoms
Genital -Dryness, Burning, Irritation
Sexual -Lack of lubrication, discomfort or pain
Urinary- Urgency, Dysuria, Recurrent UTI
|
|
| ExclusionCriteria |
| Details |
Previous local or systemic menopausal hormone therapy
Hormone -dependent tumors
Vaginal bleeding of unknown cause
Taken antibiotics 2 weeks prior to start treatment
Any other lesions in cervix, vagina and vulva
Acute infections of the genital tract, use of any vaginal therapy, severe systemic diseases, all contraindications for administration of estrogen, and participation in another study.
Patients already taking probiotics.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
CHECK FOR THE NUGENT SCORE
VAGINAL PH
CLINICAL IMPROVEMENT
VAGINAL HEALTH INDEX |
CHECK FOR THE NUGENT SCORE
VAGINAL PH
CLINICAL IMPROVEMENT
VAGINAL HEALTH INDEX
at 8weeks and 12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Combination therapy with Probiotics and
Estrogen vaginal cream versus Estrogen vaginal cream for treatment of
genitourinary syndrome in Postmenopausal women Patient will be assessed on clinical symptoms vaginal PH Nugent score vaginal health index patients will be assessed initially and after 8 and 12weeks regarding the progress of usage of probiotics and vaginal estrogen cream Outcome Changes in Nugents score, Vaginal pH, VHI and severity of
patient reported symptoms |