CTRI

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CTRI Number

CTRI/2025/01/079138 [Registered on: 21/01/2025] Trial Registered Prospectively

Last Modified On:

19/01/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A clinical trial where participants will be divided into two groups, with drug intervention as Venlafaxine in one and placebo in other group and outcome will be analysed on basis of vasomotor symptoms.

Scientific Title of Study

Venlafaxine versus placebo for treatment of vaso-motor symptoms in gynaecological cancer survivors: A double-blind, randomized, placebo-controlled 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 Soumi Banerjee
Designation	Senior Resident (M.Ch)
Affiliation	AIIMS, New Delhi
Address	Department of Obstetrics and Gynaecology, 7th floor, Mother and child block,AIIMS, New Delhi Ansari Nagar East. New Delhi DELHI 110029 India
Phone	9342682708
Fax
Email	soumibanerjeeaiims@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Nilanchali Singh
Designation	Associate Professor
Affiliation	AIIMS, New Delhi
Address	Room no 708, 7th floor,Department of Obstetrics and Gynaecology, Mother and child block, AIIMS, New Delhi, Ansari Nagar East. New Delhi DELHI 110029 India
Phone	9811343168
Fax
Email	nilanchalisingh@gmail.com

Details of Contact Person
Public Query

Name	Dr Nilanchali Singh
Designation	Associate Professor
Affiliation	AIIMS, New Delhi
Address	Room no 708, 7th floor,Department of Obstetrics and Gynaecology, Mother and child block, AIIMS, New Delhi, Ansari Nagar East. DELHI 110029 India
Phone	9811343168
Fax
Email	nilanchalisingh@gmail.com

Source of Monetary or Material Support

Intas Pharmaceuticals Ltd Thaltej,Ahmedabad Pin:380054

Primary Sponsor

Name	AIIMS, New Delhi
Address	Sri Aurobindo Marg,Ansari Nagar East, Delhi Pin: 110029
Type of Sponsor	Research institution and hospital

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 Soumi Banerjee	AIIMS, New Delhi	Room no 6,Department of Obstetrics and Gynaecology, Ground floor, Mother and child block,AIIMS, New Delhi Ansari Nagar East. South DELHI	09342682708 soumibanerjeeaiims@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Aiims Institute Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C00-D49\|\|Neoplasms,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Placebo	37.5 mg once daily orally for 12 weeks
Intervention	Velnafaxine	37.5mg once daily orally for 12 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Female
Details	Gynae cancer survivors who have received any form of treatment less than 2 years More than 18 years of age More than 14 hot flushes per week Completed treatment for gynaecological cancer Willing to participate and follow-up without discontinuation during the study period Life expectancy of more than 6month

ExclusionCriteria

Details

Severe metabolic, thromboembolic or endocrine disease
Uncontrolled hypertension
Any major psychiatric condition that would confound evaluation
Received previous treatment for hot flushes (eg. HRT)

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
Efficacy of Venlafaxine as compared to placebo on hot flashes in pre- menopausal gynae cancer survivors using 4 category Hot Flush Diary	6weeks,12weeks and 2 weeks follow up

Secondary Outcome

Outcome	TimePoints
Quality of life	6weeks,12weeks and 2 weeks follow up
Side effects	6weeks,12weeks and 2 weeks follow up
Depression and anxiety	6weeks,12weeks and 2 weeks follow up
Metabolic parameters	6weeks,12weeks and 2 weeks follow up

Target Sample Size

Total Sample Size="64"
Sample Size from India="64"
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

Date of First Enrollment (India)

20/03/2025

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="2"
Months="2"
Days="15"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

This study is a randomised , double blind, parallel group trial comparing efficacy of Venlafaxine 37.5mg daily versus placebo administered daily in gynae cancer survivors with vasomotor symptoms for 12 weeks in 64 patients (32 in each group).The study will be conducted in 3 centres of AIIMS , New Delhi ( Gynae Obs Department, NCI-AIIMS, IRCH Clinic).The primary outcome will be to compare the efficacy of Venlafaxine on hot flushes using 4 category hot flush diary at 6 weeks , 12 weeks and 2 weeks follow up..The secondary outcome will be to assess the effect on quality of life using hot flush related daily interference score, assessment of side effects (CTCAE version 5.0), assessment of anxiety and depression by HAM_A and HAM-D ams assessment of metabolic parameters (CBC,LFT, RFT,FBS,Lipid Profile) at 6 weeks, 12 weeks and 2 weeks follow up.