| CTRI Number |
CTRI/2024/03/064620 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two drugs in Urogenital Symptoms of Menopause |
|
Scientific Title of Study
|
Comparison of vaginal estrogen cream and tibolone in urogenital syndrome of menopause |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Verma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Obstetrics and Gynecology
Department of Obstetrics and Gynecology
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
07607903713 |
| Fax |
|
| Email |
drvandana19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Verma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Obstetrics and Gynecology
Department of Obstetrics and Gynecology
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
07607903713 |
| Fax |
|
| Email |
drvandana19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Verma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Obstetrics and Gynecology
Department of Obstetrics and Gynecology
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
07607903713 |
| Fax |
|
| Email |
drvandana19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Principal Investigator |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,AIIMS , RAEBARELI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vandana Verma |
All iIndia Institute of Medical Sciences |
Department of Obstetrics and Gynecology
Rae Bareli
UTTAR PRADESH |
07607903713
drvandana19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOETHICS CELL, AIIMS,RAEBARELI BIOETHICS CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAEBARELI, UTTAR PRADESH BIOETHICS CELL , ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAEBARELI , UTTAR PRADESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N952||Postmenopausal atrophic vaginitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab. Tibolone |
Tab. Tibolone 2.5 mg daily for 3 months |
| Intervention |
vaginal Estriol cream |
Estriol vaginal cream 0.1% ,0.5 mg daily for 15 days in night and then 0.3 mg twice weekly in nights for 2 months 15 days. |
|
|
Inclusion Criteria
|
| Age From |
48.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
post menopausal female of less than 60 years with genitourinary syndrome |
|
| ExclusionCriteria |
| Details |
post menopausal female with Hypertension, Diabetes Mellites, heart disease, chronic liver and kidney disease , already on any hormone therapy for menopausal symptoms, history of thromboembolism, benign or malignant breast disease or with past history of breast carcinoma, family history of breast carcinoma, abnormal uterine bleeding or known genital premalignant or malignant lesion , Endometrial thickness more than 5 mm in transvaginal sonography , BMI more than 30, on any psychiatric treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in urogenital symptoms after treatment on menopausal rating scale |
AFTER 3 MONTHS TREATMNT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vaginal Health Index & Vaginal Maturation Index |
After 3 months of starting the treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="2"
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
|
All subjects will undergo thorough clinical history regarding demographic profile the menopausal symptoms and any long-term medications etc. and will undergo clinical examination including BMI and waist circumference, breast examination, and pelvic examination and data will be entered on preformed attached proforma [9]. Complete blood picture, urine test routine/microscopy, fasting glucose level/Hb1Ac, lipid profile, serum TSH, stool for occult blood, PAP smear, vaginal pH, TVS, mammogram if breast lump will be found on examination will be conducted in each case before starting the study. Urogenital symptoms will be rated on a Menopausal Rating Scale before starting the treatment and after 3 months of treatment. Vaginal Health Index (VHI), vaginal Ph (performed from swab collected from lateral vaginal wall) and vaginal maturation index. Sample for smear will be taken from lateral vaginal wall) will be observed before starting the treatment and will be re-evaluated again after completing 3 months treatment [9]. The subjects will be randomized in 2 groups – Group 1- Will receive Estriol vaginal cream 0.1% 0.5 mg daily for 15 days in night and then 0.3 mg twice weekly in nights for 2 months 15 days. Group 2 - Will receive Tab. Tibolone 2.5 mg daily for 3 months Subjects will be followed for improvement in symptoms and for adverse effects at 1 monthly interval in both the groups. Assessment of symptomatic relief of most bothersome symptoms of GSM, side effect of medications ( nausea, vomiting, breakthrough bleeding, breast tenderness), VHI, vaginal Ph, and VMI will be done after completion of 3 months treatment. |