FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066430 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Treatment in postmenopausal women with Lenzetto (Estradiol 1.53 mg/actuation transdermal spray). 
Scientific Title of Study   A prospective, non-interventional, Active post marketing surveillance study of Lenzetto (Estradiol 1.53 mg/actuation transdermal spray) in postmenopausal women. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol Id: TML/LEN-01 Version No: 2.0 Date: 14 Sep 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Balaji More 
Designation  Vice President- Medical Services 
Affiliation  Themis Medicare Limited 
Address  11/12, Udyog Nagar, Goregaon (West), Mumbai (Suburban), Maharashtra.

Mumbai (Suburban)
MAHARASHTRA
400104
India 
Phone  8452959225  
Fax    
Email  balaji.more@themismedicare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravindra Mote 
Designation  Director 
Affiliation  Mediclin Clinical Research 
Address  2nd Floor, A Wing, Ritu Horizon, Next to Ankur School, Kanakiya Road, Mira Road (E), Thane-401107.

Thane
MAHARASHTRA
401107
India 
Phone  8888884024  
Fax    
Email  ravindra.mote@mediclincr.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Balaji More 
Designation  Vice President- Medical Services 
Affiliation  Themis Medicare Limited 
Address  11/12, Udyog Nagar, Goregaon (West), Mumbai (Suburban), Maharashtra.

Mumbai (Suburban)
MAHARASHTRA
400104
India 
Phone  8452959225  
Fax    
Email  balaji.more@themismedicare.com  
 
Source of Monetary or Material Support  
Themis Medicare Limited 
 
Primary Sponsor  
Name  Themis Medicare Limited 
Address  11/12, Udyog Nagar, Goregaon (West), Mumbai (Suburban), Maharashtra-400104. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jhantu Kumar  Burdwan Medical College and Hospital  Burdwan, West Bengal-713104, India
Barddhaman
WEST BENGAL 		 8240477220

sahadrjk1985@gmail.com 
Dr Parthasarthi Mitra  Calcutta Medical College  88, College St, College Square, Kolkata, West Bengal-700073.
Kolkata
WEST BENGAL 		 7980115887

parthasarathimitra1972@gmail.com 
Dr Nisha Chakravarti  GCS Medical College Hospital and Research Centre  Naroda Rd, Near Chamunda Bridge, Ahmedabad, Gujarat-380025.
Ahmadabad
GUJARAT 		 9687600217

dr.nisha85@yahoo.com 
Dr Tulugu Sasikala  Government Medical College and Govt. General Hospital (Old RIMSGGH)  2nd Floor, Beside FM Ward. Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH 		 9573405562

drtsasikala@gmail.com 
Dr Santosh Murlidhar Chavan  Grace Hospital  Hilton Regency, 101, First Floor, opp. Holy Family School & Dream Mall, Evershine City, Vasai East Maharshtra- 401208.
Thane
MAHARASHTRA 		 9763682040

drsantoshchavan12@gmail.com 
Dr Sabnam Parvin  Horizon Multispeciality Hospital  Kolkata, West Bengal-700014.
Kolkata
WEST BENGAL 		 8759978506

parvin.sabnam@gmail.com 
Dr Rakesh Bahadur  Janta Hospital & Maternity Centre  Amara-Akhari Bypass, Varanasi-221011, UP.
Varanasi
UTTAR PRADESH 		 9235310199

jantahospitalvns@gmail.com 
Dr Suchitra Narayan  JLN Medical College  Kala Bagh, Ajmer, Rajasthan 305001.
Ajmer
RAJASTHAN 		 7627026609

naravan_jaiprakash@yahoo.com 
Dr Sneha Bhoir  Kkasturi Medical Pvt. Ltd.  Harsh Niketan, Gaondevi Road, Bhayander West- 401101.
Thane
MAHARASHTRA 		 8356003006

drsnehabhoirmth@gmail.com 
Dr Garima Singh  Krishna Hospital  Amara-Akhari Bypass, Varanasi - 221005, UP
Varanasi
UTTAR PRADESH 		 8528221044

drsinghgarima12@gmail.com 
Dr Amrita Chaurasia  Motilal Nehru Medical College  Civil lines, George Town, Prayagraj, Allahabad, Uttar Pradesh-211002.
Allahabad
UTTAR PRADESH 		 9235750667

dramritamln211@gmail.com 
Dr Urvashi P Mahendrakumar  Rajalakshmi Hospital & Research Center  21/1, Lakshmipura Main Road, Vidyaranyapura Post, Bengaluru, Karnataka 560097.
Bangalore
KARNATAKA 		 9448696741

urvashibhatara@gmail.com 
Dr Poonam Yadav  Sarojini Naidu Medical College  Moti Katra, Mantola, Agra, Uttar Pradesh-282003.
Agra
UTTAR PRADESH 		 9411922686

dr.poonamneeraj@gmail.com 
Dr Saloni Suchak  Suchak Hospital  186, 1st Floor, Manchubhai Rd, Malad East, Mumbai, Maharashtra-400097.
Mumbai
MAHARASHTRA 		 9082805199

drsalonisuchak1717@gmail.com 
Dr Karishma Sharma  Tulsi Hospital India Limited  14/116-Civil Lines, Kanpur-208001.
Kanpur Nagar
UTTAR PRADESH 		 8318984143

dr.karishmasharma@gmail.com 
Dr Vidhi Patel  V. S. General Hospital  Ellisbridge, Ahmedabad, Gujarat-380006.
Ahmadabad
GUJARAT 		 8460427033

vpatel.drvidhi@gmail.com 
Dr Sachin Naiknaware  Vijay Vallabh Hospital  Tirupati Nagar Rd, beside Banjara Hotel, Phase 1, Virar West, Maharashtra-401303.
Thane
MAHARASHTRA 		 9819681640

drsachinnvvh@gmail.com 
Dr Megha Mane  Vivan Hospital  101, 1st, Floor, Sai Dham Tower, Next to Kaushlaya Diagnostic, Achole Road, Nalasopara East-401209.
Thane
MAHARASHTRA 		 7021553093

meghamane499@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Hurip Independent Bioethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Aatman Hospital  Approved 
Institutional Ethics Committee Burdwan Medical College  Approved 
Institutional Ethics Committee for Human Research  Approved 
Institutional Ethics Committee GCS  Approved 
Institutional Ethics Committee JLN  Approved 
Institutional Ethics Committee MLN Medical College  Approved 
Institutional Ethics Committee S.N. Medical  Approved 
Janta Hospital Ethics Committee  Approved 
Janta Hospital Ethics Committee  Approved 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Tulsi Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z798||Other long term (current) drug therapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lenzetto (Estradiol 1.53 mg/actuation transdermal spray)  Transdermal spray using a metered-dose pump-One, two or three 90 microlitre sprays administered transdermally to the inner forearm once daily for 12 weeks. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Naturally or surgically postmenopausal women (35 years or older) with a history of moderate to severe vasomotor symptoms: adequate washout period from estrogen-containing products prior to baseline assessments if previously treated. 
 
ExclusionCriteria 
Details  1. Refusal to sign the informed consent
2. Contraindications for the use of Lenzetto according to the prescribing information (below):
- Known, past or suspected breast cancer;
- Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer);
- Undiagnosed genital bleeding;
- Untreated endometrial hyperplasia;
- Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);
- Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency)
- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
- Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;
- Porphyria;
- Hypersensitivity to the active substance or to any of the excipients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To monitor the Local Skin Tolerability; occurrence of all commonly reported AEs including any clinically relevant differences observed in lab parameters, vital signs or physical examination findings: Local Skin Tolerability, Adverse Event Reporting, Lipid Profile, Vital Signs, Physical Examination.  Baseline, Week 4, Week 8, Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of climacteric symptoms/severity by five point Menopause Rating Scale (MRS).
Mean change in frequency of mild, moderate and severe vasomotor symptoms.
Mean change in severity of mild, moderate and severe vasomotor symptoms.
Overall effect of treatment as assessed by the Investigators by using Clinical Global Impression (CGI) seven point rating scale. 		 Baseline, Week 4, Week 8, Week 12 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   07/05/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Menopause hormone replacement therapy (HRT) is the most efficient treatment for symptoms of acute climacteric syndrome and for efficient prevention of long-term estrogen deficiency. Vaginal administration of low doses of estrogen is a therapy of choice for treatment and prevention of urogenital atrophy and its consequences. 

Lenzetto (Estradiol 1.53 mg/actuation transdermal spray), is approved in Europe and the same product was approved by the DCGI on 17 August 2021, for Themis Medicare Ltd to import and market the same product in India. Themis Medicare has started marketing this product in India since January 2023.

This active post marketing surveillance study has been designed to assess the safety and efficacy of Estradiol 1.53 mg/actuation transdermal spray when administered transdermally to the inner forearm once daily for 12 weeks in post-menopausal women.

 
Close