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CTRI Number  CTRI/2024/06/068270 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Types of Estrogen Therapy in Diagnosed Cases of Premature Ovarian Insufficiency. 
Scientific Title of Study   Comparing The Effect Of Estradiol Valerate And Conjugated Equine Estrogen In The Patients With Premature Ovarian Insufficiency A Randomized Control 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 Ritam Kumari 
Designation  Senior Resident  
Affiliation  University College Of Medical Sciences And GTB Hospital 
Address  Room No - 706; Department of Obstetrics and Gynecology Office; Maternity and Child Health Block; Guru Teg Bahadur Hospital; Dilshad Garden; New Delhi, India -110095

New Delhi
DELHI
110095
India 
Phone  9123409954  
Fax    
Email  ritam.ranjan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachna Agarwal 
Designation  Director professor 
Affiliation  University College Of Medical Sciences And GTB Hospital 
Address  Room No - 706; Department of Obstetrics and Gynecology Office; Maternity and Child Health Block; Guru Teg Bahadur Hospital; Dilshad Garden; New Delhi - 110095

New Delhi
DELHI
110095
India 
Phone  9123409954  
Fax    
Email  rachna_anila@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Ritam Kumari 
Designation  Senior Resident  
Affiliation  University College Of Medical Sciences And GTB Hospital 
Address  Room No - 706; Department of Obstetrics and Gynecology Office; Maternity and Child Health Block; Guru Teg Bahadur Hospital; Dilshad Garden; New Delhi - 110095

New Delhi
DELHI
110095
India 
Phone  9123409954  
Fax    
Email  ritam.ranjan@gmail.com  
 
Source of Monetary or Material Support  
Guru Teg Bahadur Hospital,Dilshad Garden, New Delhi, India - 110095 
 
Primary Sponsor  
Name  Guru Teg Bahadur Hospital 
Address  Dilshad Garden New Delhi, India -110095 
Type of Sponsor  Government medical college 
 
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 Ritam Kumari  Guru Teg Bahadur Hospital   Department of Obstetrics and Gynecology Office, Maternity and Child Health Block , Seventh Floor, Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi, India-110095
New Delhi
DELHI 		 9123409954

Ritam.ranjan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Guru Teg Bahadur Hospital Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N911||Secondary amenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conjugated equine estrogen along with oral medroxy progesterone acetate .  Conjugated equine estrogen 0.625mg daily along with oral medroxy progesterone acetate 10mg from day 15- day 25 . 
Intervention  Oral estradiol valerate along with oral medroxy progesterone acetate.  Oral estradiol valerate 2mg daily along with oral medroxy progesterone acetate 10mg from day 15- day 25. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All the women below 40 yrs with newly diagnosed POI according to ESHRE guidelines 
 
ExclusionCriteria 
Details  1.Patient with chromosomal anomalies
2.Already receiving or have received hormone therapy.
3.Hormone therapy is contraindicated like in :
a) Known case or history of breast cancer and
uterine cancer.
b) Active or history of deep venous
thrombosis (DVT) or pulmonary embolism.
c) History of clotting disorder
d) Active or history of arterial thrombotic
diseases such as myocardial infarction or
stroke
e) Chronic liver disease or dysfunction
f) Migraine with aura
4. Have received non-hormonal treatment like SSRIs, Gabapentinoids or Neurokinin B for  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Comparison between the changes in clinical parameters among two groups after 6 months of HRT.
2) Comparison between changes in radiological parameters among two groups after 6 months of HRT.
3) Comparison between changes in biochemical parameters among two groups after 6 months of HRT.  		 6months 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of side effects of HRT among two group which will include liver function tests.  6 months. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   15/06/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Ritam.ranjan@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 01-08-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
INTRODUCTION
Premature ovarian insufficiency is a condition where ovarian function declines significantly and irreversibly in women under 40, leading to elevated FSH levels and low serum estradiol. It affects about 1% of women under 40 and 0.1% under 30. Women with POI face increased risks of osteoporosis, cardiovascular disease and urogenital atrophy due to estrogen deficiency ,necessitating hormone replacement therapy(HRT) until the age of natural menopause. This study aims to compare the effects of two common estrogen formulations, oral estradiol valerate (2mg) and conjugated equine estrogen (0.625mg) , both combined with medroxyprogesterone acetate , on clinical radiological, and biochemical parameters in diagnosed POI  patients.

AIM : To compare the effect of estradiol valerate and conjugated equine estrogen in the patients with premature ovarian insufficiency.

OBJECTIVES:
PRIMARY OBJECTIVES:
1. To compare the changes in clinical parameters i.e., vasomotor symptoms, urogenital symptoms and psychological symptoms among group A and B. 
2. To compare the changes in radiological parameters i.e., urogenital atrophy, breast density and uterine parameters among group A and B. 
3. To compare the changes in biochemical parameters i.e., serum FSH, lipid profile and serum estradiol levels among group A and B. 
SECONDARY OBJECTIVES:
To compare the side effects of HRT regimen including liver function test among group A and B. 

STUDY SETTINGS : Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi - 110095

STUDY DESIGN: Prospective international study

TIME FRAME : January 2024 to June 2025

SELECTION OF CASES: Diagnosis of POI will be based on the ESHRE guidelines : (1) Infrequent cycles or amenorrhea for at least 4 months before 40 years of age and (2) an elevated follicle stimulating hormone (FSH) level >25IU/L on two occasions >4 weeks apart. Patients with chromosomal anomalies and other known non-genetic causes of POI (including autoimmune diseases, ovarian surgery, chemotherapy and radiotherapy) were excluded.

INCLUSION CRITERIA: All the women below 40 years with newly diagnosed POI. 

EXCLUSION CRITERIA : 
1. Patient with chromosomal anomalies.
2. Already receiving or have received hormone therapy.
3. Hormone therapy is  contraindicated.
4. Have received non-hormonal treatment.

SAMPLE SIZE: Considering the available studies a sample of 375 subjects are required in each group. Which is not feasible in our step. Which is not feasible in our setup. Therefore keeping in view of the limitations of subject availability and time frame , we propose to take a convenient sample of 30 subjects in each group.  

METHODLOGY: All the women visiting HRT clinic OPD of UCMS and GTBH Delhi, will be screened for primary ovarian insufficiency (POI) and a total of 60 women with diagnosis of POI, satisfying the inclusion and exclusion criteria will be recruited for the study. The recruited subjects will then be divided into two group: Group A and Group B by computer based randomization. After CTRI based randomization . After CTRI approval both groups will be started on respective drugs as mentioned.
Group A : Oral estradiol valerate 2mg along with oral medroxy progesterone acetate 10mg from day 15- day25
Group B: Conjugated equine estrogen 0.625 mg along with oral medroxy progesterone acetate 10mg from day 15 - day 25   

OUTCOME MEASURES:
Primary Outcome:
1. Comparison between the changes in clinical parameters among two groups after 6 months of HRT .
2. Comparison between the changes in radiological parameters among two groups after 6 months of HRT.
3. Comparison between the changes biochemical parameters among two groups after 6 months of HRT . 
Secondary Outcome:
Comparison of side effects of HRT among two group which will include liver function tests.

STATISTICAL ANALYSIS: 
Quantitative parameters between and within the groups will be compared by Repeated Measure ANOVA followed by Tukey’s test at 5% level of significance . Qualitative parameters will be compared between the groups by Chi Square Test/ Fischer’s Exact Test and within the group by McNemar test at 5% level of signifiance.

CONFLICT OF INTEREST:None  
 
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