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CTRI Number  CTRI/2021/06/034124 [Registered on: 09/06/2021] Trial Registered Prospectively
Last Modified On: 08/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Abnormal early puberty: A Single- center experience 
Scientific Title of Study   Isosexual Precocious Puberty: Single- center experience 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tushar Bandgar 
Designation  Professor 
Affiliation  SETH G.S Medical College, KEM Hospital 
Address  Dept of endocrinology, OPD NO 103, KEM Hospital, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820025037  
Fax    
Email  drtusharb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tushar Bandgar 
Designation  Professor 
Affiliation  SETH G.S Medical College, KEM Hospital 
Address  Dept of endocrinology, OPD NO 103, KEM Hospital, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820025037  
Fax    
Email  drtusharb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tushar Bandgar 
Designation  Professor 
Affiliation  SETH G.S Medical College, KEM Hospital 
Address  Dept of endocrinology, OPD NO 103, KEM Hospital, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820025037  
Fax    
Email  drtusharb@gmail.com  
 
Source of Monetary or Material Support  
Department of Endocrinology, Seth G.S.Medical college and KEM hospital, Acharya Dhonde marg, Parel,Mumbai  
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
Tushar Bandgar  Seth G.S. Medical college and KEM hospital  Parel Dept of endocrinology ,OPD.No 103 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9820025037

drtusharb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee- II, Seth G.S. Medical College adn KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E301||Precocious puberty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Patients with precocious puberty 
 
ExclusionCriteria 
Details  1. heterosexual forms of precocious puberty 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
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   N/A 
Date of First Enrollment (India)   20/06/2021 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION:

 

Precocious puberty (PP) is defined as the onset of secondary sexual characteristics before 8 years in girls and 9 years in boys.(1)Observational data from the US show that at age 7, 10% ofwhite girls and 23% of black girls have started puberty.(2)

Precocious puberty is classified as gonadotrophin dependent or central precocious puberty (CPP), and gonadotrophin independent or peripheral precocious puberty (PPP).Approximately 90% of girls and 25%-60% of boys with CPP have an idiopathic cause (3)(4). Rare association with genetic mutations in KISS1, KISS1R, MKRN3 and DLK1 have also been described. Clinically patients present with early pubertal changes. LH concentrations < 0.3 mIU/L are in the prepubertal range, and  >0.3 mIU/L are usually indicative of puberty (4)

 

GnRH stimulation test should be done in clinically equivocal cases.In the GnRH stimulation test, pubertal individuals have a stimulated peak LH of at least ~4-6 mIU/L, whereas prepubertal children will have a minimal increase from baseline.(5)

 

 

 

Other than arresting puberty, for physical and psychological reasons, preserving adult height is an important long term goal(4)

The most common treatment used for CPP is intramuscularleuprolide depot.

For gonadotrophin-independent precocious puberty, treatment options include aromatase inhibitors, SERM, and androgen synthesis inhibitors like ketoconazole.

Surgery is the treatment of choice for gonadal tumors.

 

There are only a few studies reported from India describing this condition. Hence, we aim to retrospectively study patients’ clinical, biochemical, and treatment profiles with precocious puberty from a single center in Western India.

 

AIMS AND OBJECTIVES

·       To study the clinical, biochemical, imaging, management, and outcome of patients with precocious puberty.

 

TYPE OF STUDY: Retrospective study

 

SAMPLE SIZE: All patients who had presented to endocrine OPDwill be included in the study (approximately 100 patients).

 

INCLUSION CRITERIA:

·       Isosexual precocious puberty

 

EXCLUSION CRITERIA:

·       Patients with heterosexual forms of precocious puberty (e.g congenital adrenal hyperplasia).

·       Patients with premature thelarche, premature puberache.

 

 

STUDY SETTINGS:

The data of patients with precocious puberty will be retrieved from medical records from January 2000 till February 2021 at Seth G.S. Medical college and KEM hospital, Parel, Mumbai.

This will encompass clinical features, biochemical investigations, imaging, management, and outcome details.

 

METHODOLOGY:

This is a retrospective study conducted at a tertiary health care center. Data will be collected (both baseline and follow up) from medical records of patients withprecocious puberty. The clinical features (age of presentation, age of diagnosis, gender, family history, symptoms, examination findings), biochemical characteristics (FSH, LH, testosterone, estradiol, 17 OHP, basal cortisol, TFT, beta HCG, GnRH stimulation test), radiological investigations (Xray, USG pelvis, MRI brain etc.) will be recorded.

 
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