| 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
|
|
|
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
|
|
|
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. |