FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/106700 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Topical testosterone therapy following Hypospadias repair in paediatric patients. 
Scientific Title of Study   A Randomised Controlled Trial evaluating the effect of Topical Testosterone Therapy following Hypospadias repair in Paediatric patients. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Prakash 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli, U.P. 
Address  Room no. - 604, OPD Block, Paediatric Surgery Department, AIIMS Campus, Munshiganj, Raebareli - 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  8299739245  
Fax    
Email  divya03k@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Divya Prakash 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli, U.P. 
Address  Room no. - 604, OPD Block, Paediatric Surgery Department, AIIMS Campus, Munshiganj, Raebareli - 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  8299739245  
Fax    
Email  divya03k@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Divya Prakash 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli, U.P. 
Address  Room no. - 604, OPD Block, Paediatric Surgery Department, AIIMS Campus, Munshiganj, Raebareli - 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  8299739245  
Fax    
Email  divya03k@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Munshiganj, Uttar Pradesh, India - 229405 
 
Primary Sponsor  
Name  Medical Research Unit MRU AIIMS Raebareli 
Address  MRU, All India Institute of Medical Sciences, AIIMS Raebareli, Munshiganj, Uttar Pradesh, India - 229405 
Type of Sponsor  Other [Government/ Institutional] 
 
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 Divya Prakash  All India Institute of Medical Sciences, Raebareli  Department of Paediatric Surgery, AIIMS, Raebareli, Munshiganj. 229405
Rae Bareli
UTTAR PRADESH 
8299739245

divya03k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q548||Other hypospadias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group (CG)   CG group will be receiving a placebo (neutral body lotion) 
Intervention  Intervention/ Testosterone group (TG)  TG - receiving dermal testosterone gel. 
 
Inclusion Criteria  
Age From  12.00 Month(s)
Age To  18.00 Year(s)
Gender  Male 
Details  children with mid/ proximal penile hypospadias 
 
ExclusionCriteria 
Details  Children with underlying disorders of sexual differentiation.
Children with any other variants of hypospadias 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the penile dimensions (such as stretched dorsal/ventral penile length, Penile diameter and glans circumference) between the testosterone and control groups post-hypospadias repair   Baseline,
1 month of starting the treatment,
3months of starting the treatment,
6months of starting the treatment and
12 months of starting the treatment 
 
Secondary Outcome  
Outcome  TimePoints 
•To assess differences in post operative complications (e.g., Urethro-cutaneous fistula & Meatal Stenosis).  Baseline, 1month, 3 months, 6months & 12 months 
To evaluate systemic & local complications of dermal testosterone therapy  Baseline, 1month, 3 months, 6 months, & 12 months.
Or at every visit 
To assess hormonal changes (Ts), LH/FSH) over time  Baseline, 1 month, 3 months, 6 months, & 12 months.  
To monitor changes in bone mineral density via DEXA (dual-energy x-ray absorptiometry scan)  At baseline & 12 months 
To evaluate caregiver satisfaction using standardized scoring systems (Pediatric penile perception score, Likert).  At 3 months & 12 months. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="314" 
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)   03/04/2026 
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)   Open to Recruitment 
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  

Hypospadias is among the most common anatomical congenital anomalies affecting the male external genitalia, where surgical correction is the only treatment modality. While surgical techniques have improved, many post-pubertal patients remain dissatisfied with penile size, appearance, and functional outcomes, particularly in cases of moderate/proximal hypospadias with chordee.

Although preoperative hormonal stimulation (PHS) is well established to improve local tissue characteristics and penile dimensions before surgery, the potential benefits of postoperative hormonal stimulation (PHS-post) have not been adequately explored. Given the documented dissatisfaction and psychosocial impact among adolescents and adults post-repair, topical testosterone application after surgical correction may offer additional benefits in penile growth, cosmesis, and quality of life.

This open-label, randomised controlled trial aims to evaluate the efficacy of dermal testosterone gel applied postoperatively in children who have undergone hypospadias repair. A total of 50 patients (minimum 25 in each group), aged between 1 and 18 years, who meet the inclusion criteria will be enrolled. Participants will be randomised into two arms: the intervention group (TG) receiving dermal testosterone gel and the control group (CG) receiving a placebo (neutral body lotion). Parents/caregivers will be instructed on proper application technique.

Outcomes will be measured over a 12-month period and will include penile dimensions (dorsal/ventral stretched penile length, glans circumference, and penile diameter), incidence of postoperative complications (fistula, meatal stenosis), hormonal parameters (serum testosterone, LH, FSH), bone mineral density changes via DEXA, and caregiver-reported satisfaction using validated scales (PPPS, Likert).

This study will provide critical insights into the therapeutic potential of postoperative hormonal therapy in improving both physical and psychosocial outcomes following hypospadias surgery. The results could establish a new standard of care, particularly in moderate to severe hypospadias or in cases with post-operative complications. It may also inform long-term follow-up practices and quality of life assessments in these patients.

 
Close